FDA 510(k) Application Details - K023633

Device Classification Name Image, Illumination, Fiberoptic, For Endoscope

  More FDA Info for this Device
510(K) Number K023633
Device Name Image, Illumination, Fiberoptic, For Endoscope
Applicant SOVIS OPTIQUE
700 THIRTEENTH ST. NW
SUITE 1200
WASHINGTON, DC 20005 US
Other 510(k) Applications for this Company
Contact FRANCES K WU
Other 510(k) Applications for this Contact
Regulation Number 876.1500

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

  More FDA Info for this Product Code
Date Received 10/29/2002
Decision Date 12/31/2002
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