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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Surgical, General & Plastic Surgery
510(k) Number K901107
Device Name MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC
Applicant
United States Surgical, A Division of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact STEPHEN REITZLER
Correspondent
United States Surgical, A Division of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact STEPHEN REITZLER
Regulation Number878.4800
Classification Product Code
GDJ  
Date Received03/08/1990
Decision Date 04/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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