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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K900129
FOIA Releasable 510(k) K900129
Device Name MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER*
Applicant
United States Surgical, A Division of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact CURTIS RAYMOND
Correspondent
United States Surgical, A Division of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact CURTIS RAYMOND
Regulation Number878.4750
Classification Product Code
GDW  
Date Received01/03/1990
Decision Date 02/27/1990
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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