FDA 510(k) Application Details - K954879

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K954879
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	UNITED STATES ENDOSCOPY GROUP, INC. 9300 PROGRESS PKWY. MENTOR, OH 44060 US Other 510(k) Applications for this Company
Contact	GRETCHEN YOUNKER Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/1995
Decision Date	03/29/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review