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FDA 510(k) Application Details - K191696
Device Classification Name
More FDA Info for this Device
510(K) Number
K191696
Device Name
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
Applicant
Cook Biotech Incorporated
1425 Innovation Place
West Lafayette, IN 47906 US
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Contact
Perry W. Guinn
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Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OXN
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More FDA Info for this Product Code
Date Received
06/25/2019
Decision Date
12/27/2019
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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