FDA 510(k) Application Details - K212717

Device Classification Name	Gown, Isolation, Surgical   More FDA Info for this Device
510(K) Number	K212717
Device Name	Gown, Isolation, Surgical
Applicant	Paneffort, LLC Rochester, NY 14626 US Other 510(k) Applications for this Company
Contact	Harry Harry Other 510(k) Applications for this Contact
Regulation Number	878.4040   More FDA Info for this Regulation Number
Classification Product Code	FYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2021
Decision Date	11/30/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review