FDA 510(k) Application Details - K993041

Device Classification Name Cystoscope And Accessories, Flexible/Rigid

  More FDA Info for this Device
510(K) Number K993041
Device Name Cystoscope And Accessories, Flexible/Rigid
Applicant THE OLYMPUS OPTICAL CO.
1129 BLOOMFIELD AVE.
WEST CALDWELL, NJ 07006 US
Other 510(k) Applications for this Company
Contact ROBERT SHIFF
Other 510(k) Applications for this Contact
Regulation Number 876.1500

  More FDA Info for this Regulation Number
Classification Product Code FAJ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 09/10/1999
Decision Date 03/30/2000
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

FDA Source Information for K993041


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact