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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 K830503
Device Name LIGACLIP TITANIUM LIGATING CLIP
Applicant
Ethicon, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ethicon, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4300
Classification Product Code
FZP  
Date Received02/16/1983
Decision Date 03/08/1983
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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