FDA 510(k) Application Details - K132890

Device Classification Name	Catheter, Suprapubic (And Accessories)   More FDA Info for this Device
510(K) Number	K132890
Device Name	Catheter, Suprapubic (And Accessories)
Applicant	MEDIPLUS LTD. UNIT 7, THE GATEWAY CENTRE CORONATION RD, CRESSEX BUS. PK. HIGH WYCOMBE, BUCKS HP12 35U GB Other 510(k) Applications for this Company
Contact	PAUL DRYDEN Other 510(k) Applications for this Contact
Regulation Number	876.5090   More FDA Info for this Regulation Number
Classification Product Code	KOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2013
Decision Date	01/17/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review