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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K812323
Device Name PDS* ABSORBABLE LIGATING CLIPS
Applicant
ETHICON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ETHICON, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4300
Classification Product Code
FZP  
Date Received08/17/1981
Decision Date 11/16/1981
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
Recalls CDRH Recalls
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