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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
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