FDA 510(k) Application Details - K152476

Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin

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510(K) Number K152476
Device Name Tissue Adhesive For The Topical Approximation Of Skin
Applicant CHEMENCE MEDICAL PRODUCTS INC.
200 Technology Drive
Alpharetta, GA 30005 US
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Contact Kenneth Broadley
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Regulation Number 878.4010

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Classification Product Code MPN
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Date Received 08/31/2015
Decision Date 02/09/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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