FDA 510(k) Application Details - K041494

Device Classification Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology

  More FDA Info for this Device
510(K) Number K041494
Device Name Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Applicant OLYMPUS CORPORATION
TWO CORPORATE CENTER DRIVE
PO BOX 9058
MELVILLE, NY 11747-3157 US
Other 510(k) Applications for this Company
Contact TINA STEFFANIE-OAK
Other 510(k) Applications for this Contact
Regulation Number 876.1500

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

  More FDA Info for this Product Code
Date Received 06/04/2004
Decision Date 07/01/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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