FDA 510(k) Application Details - K973249

Device Classification Name Laparoscope, General & Plastic Surgery

  More FDA Info for this Device
510(K) Number K973249
Device Name Laparoscope, General & Plastic Surgery
Applicant ARMSTRONG HEALTHCARE LTD.
RIVERLOCK HOUSE,
SPRING GARDENS ROAD
HIGH WYCOMBE HP13 7AG GB
Other 510(k) Applications for this Company
Contact PATRICK A FINLAY
Other 510(k) Applications for this Contact
Regulation Number 876.1500

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

  More FDA Info for this Product Code
Date Received 08/29/1997
Decision Date 11/26/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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