FDA 510(k) Application Details - K213163

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K213163
Device Name	Mesh, Surgical
Applicant	Alafair Biosciences Inc 6101 W Courtyard Drive Suite 2-225 Austin, TX 78730 US Other 510(k) Applications for this Company
Contact	Angela Mallery Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2021
Decision Date	10/29/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review