FDA 510(k) Application Details - K160364

Device Classification Name	More FDA Info for this Device
510(K) Number	K160364
Device Name	VersaWrap Tendon Protector
Applicant	Alafair Biosciences Inc 3925 W. Braker Lane, Floor #3 Austin, TX 78759 US Other 510(k) Applications for this Company
Contact	Ben Walthall 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	02/09/2016
Decision Date	06/10/2016
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