FDA 510(k) Application Details - K962897

Device Classification Name	Gastroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K962897
Device Name	Gastroscope And Accessories, Flexible/Rigid
Applicant	PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. MIRAMAR, FL 33025 US Other 510(k) Applications for this Company
Contact	PAUL SILVA Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/25/1996
Decision Date	10/04/1996
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