Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K791191Substantially Equivalent

The Galassia System

Ariel, Mchenry IL / Traditional, Substantially Equivalent

K791191 is the FDA 510(k) clearance record for THE GALASSIA SYSTEM, cleared for Ariel on . FDA records list 2 510(k) clearances for Ariel, from to . As of , FDA records show no recalls naming K791191.

Clearance record

Decision date
Received
(90 days to decision)
Review panel
Unknown
Applicant
Ariel 803 N. Front St. Suite 3, Mchenry IL
Third party review
No