FDA 510(k) Application Details - K110214

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K110214
Device Name	Catheter, Retention Type, Balloon
Applicant	PERCUVISION 200 HOMER AVE, 2ND FLOOR ASHLAND, MA 01721 US Other 510(k) Applications for this Company
Contact	FIDES MALDONADO Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2011
Decision Date	05/27/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review