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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 K820811
Device Name PROXIMATE DISPOSABLE SKIN STAPLERS
Applicant
ETHICON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ETHICON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4740
Classification Product Code
GAG  
Date Received03/23/1982
Decision Date 08/20/1982
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
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