FDA 510(k) Application Details - K003749

Device Classification Name	Gown, Isolation, Surgical   More FDA Info for this Device
510(K) Number	K003749
Device Name	Gown, Isolation, Surgical
Applicant	BANTA HEALTHCARE PO BOX 4341 CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	YOLNDA SMITH 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	12/04/2000
Decision Date	02/23/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review