FDA 510(k) Application Details - K981286

Device Classification Name	Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration   More FDA Info for this Device
510(K) Number	K981286
Device Name	Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Applicant	ARMM, INC. 17744 SAMPSON LN. HUNTINGTON BEACH, CA 92647 US Other 510(k) Applications for this Company
Contact	ROGER WOOD Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KDH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/1998
Decision Date	06/19/1998
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