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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar, Gastro-Urology
510(k) Number K942885
Device Name AUTO SUTURE MODIFIED GRIP
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact JONATHAN GILBERT
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact JONATHAN GILBERT
Regulation Number876.5090
Classification Product Code
FBQ  
Date Received06/17/1994
Decision Date 08/22/1994
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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