FDA 510(k) Application Details - K990206

Device Classification Name	Detector, Leak, Blood   More FDA Info for this Device
510(K) Number	K990206
Device Name	Detector, Leak, Blood
Applicant	SERIM RESEARCH CORP. 23565 REEDY DR. ELKHART, IN 46514 US Other 510(k) Applications for this Company
Contact	ROBERT J CARRICO Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FJD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/1999
Decision Date	04/21/1999
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