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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 K162352
Device Name derma+flex QS High Viscosity Tissue Adhesive
Applicant
Chemence Medical, Inc.
200 Technology Dr.
Alpharetta,  GA  30005
Applicant Contact Kenneth Broadley
Correspondent
Chemence Medical, Inc.
200 Technology Dr.
Alpharetta,  GA  30005
Correspondent Contact Kenneth Broadley
Regulation Number878.4010
Classification Product Code
MPN  
Date Received08/23/2016
Decision Date 12/22/2016
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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