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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 K150840
Device Name Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier
Applicant
ETHICON ENDO-SURGERY, LLC
475 CALLE C SUITE 202
GUAYNABO,  PR  00969
Applicant Contact Marjorie Medina
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 CREEK ROAD
CINCINNATI,  OH  45242
Correspondent Contact Emily Kruetzkamp
Regulation Number878.4300
Classification Product Code
FZP  
Date Received03/30/2015
Decision Date 09/10/2015
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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