FDA 510(k) Application Details - K240205

Device Classification Name Laparoscope, General & Plastic Surgery

  More FDA Info for this Device
510(K) Number K240205
Device Name Laparoscope, General & Plastic Surgery
Applicant Veol Medical Technologies Pvt Ltd.
A 747, MIDC Pawane, TTC Industrial Area, Kopar Khairane
Navi Mumbai 400705 IN
Other 510(k) Applications for this Company
Contact Sneha Pandit
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 01/25/2024
Decision Date 04/15/2024
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

FDA Source Information for K240205


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