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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 K163645
Device Name DERMABOND PRINEO Skin Closure System
Applicant
Ethicon, LLC
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Applicant Contact Joice Pappan
Correspondent
Ethicon, LLC
Rte. 22 W. P.O. Box 151
Somerville,  NJ  08876
Correspondent Contact Joice Pappan
Regulation Number878.4011
Classification Product Code
OMD  
Date Received12/23/2016
Decision Date 04/21/2017
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
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