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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Obstetrical
510(k) Number K903205
Device Name AUTO SUTURE(R) ENDOSCOPIC CLAMP
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact STEVE REITZLER
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact STEVE REITZLER
Regulation Number884.4400
Classification Product Code
HDA  
Date Received07/20/1990
Decision Date 10/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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