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Catheters / Pleural effusion / Chest tube / Malignant pleural effusion / Port / Pleural cavity / Medical device / Pleurodesis / ISO 10993 / Medicine / Medical equipment / Medical technology


Traditional 510(k) for Rocket IPC System Q Rocketmedical The eCopy is an exact duplicate of the paper copy; Rev ised 510(k) K123033 SUMMARY
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Document Date: 2013-03-08 15:18:02

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File Size: 275,35 KB

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City

Wear United Kingdom / Washington / Tyne / Wear Industrial Estate / /

Company

K123033 Trade / Tracy Charlton Regulatory Affairs Manager Rocket Medical Plc / Rocket Medical Plc. / CareFusion / /

Event

FDA Phase / /

Facility

General Hospital / New Hamrpshire Avenue Documnent Control Center / /

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IndustryTerm

health care products / exit site / collection device / wound site / announcements concerning your device / catheter devices / technology characteristics / predicate device / manufacturing practice requirements / evaluation ofimed/cal devices / rmedical devices / marketed predicate devices / manufacturing practice / marketed predicate device / identified predicate device / evaluation ai med/cal devices / /

MedicalCondition

disease / dyspnea / malignant pleural effusion / delayed-type hypersensitivity / pleural effusion / recurrent / pleural effusion / irritation / /

MedicalTreatment

pleurodesis / Intravascular Catheters / catheter / drainage / Catheters / Radiation / /

Organization

Division of Postmarket Surveillance / M.B.A. Director Division of Anesthesiology / Central Intelligence Agency / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Eta / FDA / General Hospital / Division of Small Manufacturers / International and Consumer Assistance / Division SIgn-Off frL Division / DEPARTMENT OF HEALTH &zHUMAN SERVICES Public Health Service Food and Dng Administration / CDRH's office of Surveillance / New Hamrpshire Avenue Documnent Control Center / Center for Devices / /

Person

Tracy Charlton / Silver Spring / Roc / Anthony D. Watson / /

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Position

Manager Summary Preparation Date / Official / Regulatory Affairs Manager / General / Manager Paged6 / /

Product

Federal Food / /

ProvinceOrState

Maryland / Washington / /

Technology

Radiation / http / same technologies / /

URL

www.fda.gzov/MedicalDevices/ResourcesforYou/Industrv/default.htm / http /

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