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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin
510(k) Number K100423
Device Name DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
Applicant
Ethicon, Inc.
P.O. Box 151, Route 22 W.
Somerville,  NJ  08876 -0151
Applicant Contact NEELU MEDHEKAR
Correspondent
Ethicon, Inc.
P.O. Box 151, Route 22 W.
Somerville,  NJ  08876 -0151
Correspondent Contact NEELU MEDHEKAR
Regulation Number878.4010
Classification Product Code
MPN  
Date Received02/16/2010
Decision Date 05/04/2010
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
Recalls CDRH Recalls
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