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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 K050344
FOIA Releasable 510(k) K050344
Device Name LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER
Applicant
ETHICON ENDO SURGERY, INC.
4545 CREEK ROAD
CINCINNATI,  OH  45242
Applicant Contact KIMBERLY SHOEMAKER
Correspondent
ETHICON ENDO SURGERY, INC.
4545 CREEK ROAD
CINCINNATI,  OH  45242
Correspondent Contact KIMBERLY SHOEMAKER
Regulation Number878.4300
Classification Product Code
FZP  
Date Received02/11/2005
Decision Date 03/14/2005
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
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