FDA 510(k) Application Details - K963344

Device Classification Name Sigmoidoscope And Accessories, Flexible/Rigid

  More FDA Info for this Device
510(K) Number K963344
Device Name Sigmoidoscope And Accessories, Flexible/Rigid
Applicant VISION-SCIENCES, INC.
6 STRATHMORE RD.
NATICK, MA 01760 US
Other 510(k) Applications for this Company
Contact PAMELA PAPINEAU
Other 510(k) Applications for this Contact
Regulation Number 876.1500

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

  More FDA Info for this Product Code
Date Received 08/26/1996
Decision Date 11/21/1996
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