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FDA 510(k) Application Details - K152476
Device Classification Name
Tissue Adhesive For The Topical Approximation Of Skin
More FDA Info for this Device
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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More FDA Info for this Product Code
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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