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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K000337
Device Name MTP DISPOSABLE TROCAR VALVES
Applicant
Mtp Medical Technical Promotion GmbH
600 Corporate Pointe
Culver City,  CA  90230
Applicant Contact KEVIN KENNAN
Correspondent
Mtp Medical Technical Promotion GmbH
600 Corporate Pointe
Culver City,  CA  90230
Correspondent Contact KEVIN KENNAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/03/2000
Decision Date 04/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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