FDA 510(k) Application Details - K011016

Device Classification Name Laparoscope, General & Plastic Surgery

  More FDA Info for this Device
510(K) Number K011016
Device Name Laparoscope, General & Plastic Surgery
Applicant LSI SOLUTIONS
2144 BRIGHTON-HENRIETTA TOWN
LINE RD.
ROCHESTER, NY 14623 US
Other 510(k) Applications for this Company
Contact CHRISTINE E EHMANN
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 04/04/2001
Decision Date 04/27/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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