FDA 510(k) Application Details - K963044

Device Classification Name Light Source, Endoscope, Xenon Arc

  More FDA Info for this Device
510(K) Number K963044
Device Name Light Source, Endoscope, Xenon Arc
Applicant CORIN U.S.A.
10500 UNIVERSITY CENTER DR.,
SUITE 190
TAMPA, FL 33612 US
Other 510(k) Applications for this Company
Contact JACK THOMAS
Other 510(k) Applications for this Contact
Regulation Number 876.1500

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

  More FDA Info for this Product Code
Date Received 08/05/1996
Decision Date 09/20/1996
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