FDA 510(k) Application Details - K974647

Device Classification Name	Drape, Surgical   More FDA Info for this Device
510(K) Number	K974647
Device Name	Drape, Surgical
Applicant	CUSTOMED, INC. CALLE IGUALDAD #7 FAJARDO, PR 00738 US Other 510(k) Applications for this Company
Contact	GLADYNELL RODRIGUEZ Other 510(k) Applications for this Contact
Regulation Number	878.4370   More FDA Info for this Regulation Number
Classification Product Code	KKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/1997
Decision Date	01/05/1998
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