FDA 510(k) Application Details - K960068

Device Classification Name Endoscope Holder

  More FDA Info for this Device
510(K) Number K960068
Device Name Endoscope Holder
Applicant OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
Other 510(k) Applications for this Company
Contact BARRY E SANDS
Other 510(k) Applications for this Contact
Regulation Number 876.1500

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

  More FDA Info for this Product Code
Date Received 01/05/1996
Decision Date 05/05/1997
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



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