FDA 510(k) Application Details - K131803

Device Classification Name	Accessories, Catheter, G-U   More FDA Info for this Device
510(K) Number	K131803
Device Name	Accessories, Catheter, G-U
Applicant	SOLACE THERAPEUTICS 135 NEWBURY ST FRAMINGHAM, MA 01701 US Other 510(k) Applications for this Company
Contact	WILLIAM GRUBER Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KNY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2013
Decision Date	08/20/2013
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