FDA 510(k) Application Details - K993445

Device Classification Name	Endoscope, Rigid   More FDA Info for this Device
510(K) Number	K993445
Device Name	Endoscope, Rigid
Applicant	OMNISONICS MEDICAL TECHNOLOGIES 7 TIFFANY TRAIL HOPKONTON, MA 01748 US Other 510(k) Applications for this Company
Contact	DEBBIE IAMPIETRO Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/12/1999
Decision Date	12/06/1999
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