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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cutaneous Tissue Adhesive With Mesh
510(k) Number K133864
Device Name DERMABOND PRINEO SKIN CLOSURE SYSTEM
Applicant
ETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Applicant Contact DONNA MARSHALL
Correspondent
ETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact DONNA MARSHALL
Regulation Number878.4011
Classification Product Code
OMD  
Date Received12/19/2013
Decision Date 03/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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