FDA 510(k) Application Details - K963354

Device Classification Name	Mini Endoscope, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K963354
Device Name	Mini Endoscope, Gastroenterology-Urology
Applicant	FIVE STAR MEDICAL, INC. 4767 WREN COURT CHARLOTTESVILLE, VA 22911 US Other 510(k) Applications for this Company
Contact	BEVERLY J STEWART Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/1996
Decision Date	09/08/1997
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