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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Staple, Removable (Skin)
510(k) Number K760734
Device Name REGULAR AND WIDE SKIN STAPLES
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 Number878.4760
Classification Product Code
GDT  
Date Received09/28/1976
Decision Date 11/03/1976
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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