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FDA 510(k) Application Details - K162352
Device Classification Name
Tissue Adhesive For The Topical Approximation Of Skin
More FDA Info for this Device
510(K) Number
K162352
Device Name
Tissue Adhesive For The Topical Approximation Of Skin
Applicant
CHEMENCE MEDICAL INC
200 TECHNOLOGY DRIVE
Alpharetta, GA 30005 US
Other 510(k) Applications for this Company
Contact
Kenneth Broadley
Other 510(k) Applications for this Contact
Regulation Number
878.4010
More FDA Info for this Regulation Number
Classification Product Code
MPN
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More FDA Info for this Product Code
Date Received
08/23/2016
Decision Date
12/22/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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