FDA 510(k) Application Details - K062779

Device Classification Name Laparoscope, General & Plastic Surgery

  More FDA Info for this Device
510(K) Number K062779
Device Name Laparoscope, General & Plastic Surgery
Applicant NEW WAVE SURGICAL CORPORATION
55 NORTHERN BLVD.
SUITE 200
GREAT NECK, NY 11011 US
Other 510(k) Applications for this Company
Contact SID MATHUR
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 09/18/2006
Decision Date 10/05/2006
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 Y
Expedited Review



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