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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 K110699
FOIA Releasable 510(k) K110699
Device Name LIGAMAX 5
Applicant
Ethicon Endo-Sugery, LLC
4545 Creek Rd.
Blue Ash,  OH  45242
Applicant Contact EMILY KRUETZKAMP
Correspondent
Ethicon Endo-Sugery, LLC
4545 Creek Rd.
Blue Ash,  OH  45242
Correspondent Contact EMILY KRUETZKAMP
Regulation Number878.4300
Classification Product Code
FZP  
Date Received03/14/2011
Decision Date 03/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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