FDA 510(k) Application Details - K992447

Device Classification Name Light Source, Fiberoptic, Routine

  More FDA Info for this Device
510(K) Number K992447
Device Name Light Source, Fiberoptic, Routine
Applicant ANGIOLAZ, INC.
INDUSTRIAL PARK
BELLOWS FALLS, VT 05101-0556 US
Other 510(k) Applications for this Company
Contact JOHN PLUMADORE
Other 510(k) Applications for this Contact
Regulation Number 876.1500

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

  More FDA Info for this Product Code
Date Received 07/22/1999
Decision Date 10/20/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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