FDA 510(k) Application Details - K961442

Device Classification Name	Tray, Catheterization, Sterile Urethral, With Or Without Catheter   More FDA Info for this Device
510(K) Number	K961442
Device Name	Tray, Catheterization, Sterile Urethral, With Or Without Catheter
Applicant	CUSTOMED, INC. CALLE IGUALDAD #7 FAJARDO, PR 00738 US Other 510(k) Applications for this Company
Contact	FELIX B SANTOS Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	FCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/1996
Decision Date	05/09/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review