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Food and Drug Administration / Food law / Fluid dynamics / Negative-pressure wound therapy / Medical device / Pump / Drain / Suction / Bedsore / Medicine / Medical equipment / Surgical instruments


JAN[removed]1z s- 510(k) Summary of Safety and Effectiveness Date prepared:
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Document Date: 2012-02-27 00:31:11

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File Size: 162,14 KB

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City

Derby / /

Company

Simex Medlizintechnik GmbH / Medica-Rents Co LTD / K1 12458 Trade / /

Country

Germany / United States / /

Event

FDA Phase / /

Facility

Fort Worth TX / /

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IndustryTerm

quality systems management / metal / Internet address http /

MedicalCondition

infectious material / infectious materials / burns / /

MedicalTreatment

Plastic Surgery / surgery / Negative Pressure Wound Therapy / /

Organization

Division of Postmarket Surveillance / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use Statement / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Surgical / Orthopedic and Restorative Devices Office / Mark N. Melkerson Director Division of Surgical / CDRH's office of Surveillance / /

Person

Silver Spring / Dina L.Weissman / Mark N. Melkerson / /

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Position

Regulatory Affairs Consultant / General / /

Product

Federal Food / /

ProvinceOrState

Maryland / Connecticut / /

Technology

radiation / /

URL

http /

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