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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Umbilical
510(k) Number K934525
Device Name AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER
Applicant
United States Surgical, A Division OF Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact PAUL D SMOLENSKI
Correspondent
United States Surgical, A Division OF Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact PAUL D SMOLENSKI
Regulation Number884.4530
Classification Product Code
HFW  
Date Received09/17/1993
Decision Date 02/14/1994
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
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