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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 K994066
Device Name MTP DISPOSABLE TROCARS
Applicant
Mtp Medical Technical Promotion GmbH
P.O. Box 1954
Culver City,  CA  90232
Applicant Contact KEVIN KENNAN
Correspondent
Mtp Medical Technical Promotion GmbH
P.O. Box 1954
Culver City,  CA  90232
Correspondent Contact KEVIN KENNAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/01/1999
Decision Date 01/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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