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FDA 510(k) Application Details - K171442
Device Classification Name
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510(K) Number
K171442
Device Name
Exofin Fusion Skin Closure System
Applicant
Chemence Medical, Inc.
200 Technology Drive
Alpharetta, GA 30005 US
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Contact
Kenneth Broadley
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Regulation Number
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Classification Product Code
OMD
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Date Received
05/16/2017
Decision Date
09/25/2017
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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