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 Other 510(k) Applications for this Company
Contact	Perry W. Guinn Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXN Other 510(k) Applications for this Device   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