Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K837412Substantially Equivalent

Saturne I Linear Accelerator

Cgr Medical Corp., Columbia MD / Traditional, Substantially Equivalent

K837412 is the FDA 510(k) clearance record for SATURNE I LINEAR ACCELERATOR, cleared for Cgr Medical Corp. on . FDA records list 20 510(k) clearances for Cgr Medical Corp., from to . As of , FDA records show no recalls naming K837412.

Clearance record

Decision date
Received
(68 days to decision)
Review panel
Unknown
Applicant
Cgr Medical Corp. 10150 Old Columbia Rd., Columbia MD
Third party review
No