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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stapler, Surgical
510(k) Number K771177
Device Name SURGICAL STAPLING INSTRU., AUTO, SUTURE
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4740
Classification Product Code
GAG  
Date Received06/30/1977
Decision Date 10/18/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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