FDA 510(k) Application Details - K240817

Device Classification Name	More FDA Info for this Device
510(K) Number	K240817
Device Name	VersaWrap
Applicant	Alafair Biosciences Inc. 6101 W Courtyard Dr Ste 1-225 Austin, TX 78730 US Other 510(k) Applications for this Company
Contact	Sarah Mayes Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2024
Decision Date	06/14/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review