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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 K213512
Device Name DERMABOND PRINEO Skin Closure System
Applicant
Ethicon, Inc.
1000 Rte. 202 S.
Raritan,  NJ  08869
Applicant Contact Noorhidayah Norizan
Correspondent
Ethicon, Inc.
1000 Rte. 202 S.
Raritan,  NJ  08869
Correspondent Contact Noorhidayah Norizan
Regulation Number878.4011
Classification Product Code
OMD  
Date Received11/02/2021
Decision Date 12/07/2021
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
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