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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 K760732
Device Name SKIN STAPLING INSTRUMENT
Applicant
Ethicon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ethicon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4740
Classification Product Code
GAG  
Date Received09/28/1976
Decision Date 11/03/1976
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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