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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K123114
Device Name ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
Applicant
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Applicant Contact SUSAN LIN
Correspondent
ETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE,  NJ  08876 -0151
Correspondent Contact SUSAN LIN
Regulation Number878.4750
Classification Product Code
GDW  
Date Received10/03/2012
Decision Date 02/05/2013
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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