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Endoscopy / Benign prostatic hyperplasia / Laparoscopic surgery / Esophageal cancer / Invasiveness of surgical procedures / Ablation / Arthroscopy / ICD-9-CM Volume 3 / Laser surgery / Medicine / Surgery / Medical terms


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue
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Document Date: 2014-11-12 09:21:37

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Company

K131987 Trade / ASCLEPION LASER TECHNOLOGIES GmbH / Trimedyne Holmium Laser Systems / SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH / /

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Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

announcements concerning your device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /

MedicalCondition

Benign Prostatic Hypertrophy / tumors / Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile / Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias / Discectomy Pulmonary / Osler-WeberRenu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss / Bladder Tumors / renal calculi / endoscopic pulmonary surgery / Urethral Tumors / /

MedicalTreatment

sinus Surgery / endonasal surgery / Appendectomy / Skin incision / incision / Orthopedic surgery / laser Ablation / endoscopic surgery / plastic surgery / Lithotripsy / surgery / /

Organization

Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / office of Device Evaluation Guidance / Surgical Devices Office / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / F.A.C.S. Director Division / Device Evaluation Center for Devices and Radiological Health Enclosure / CDRH’s office of Surveillance / /

Person

Surgery Open / Silver Spring / Brüesseler Straße / Antje Katzer / Binita S. Ashar / DIN EN / /

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Position

International Regulatory Affairs Manager / Wine Stains Papillomas General / General / /

Product

Federal Food / /

ProvinceOrState

Maryland / /

Technology

radiation / Laser / fiber optic / Laser system / /

URL

http /

SocialTag