510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K827379Substantially Equivalent

X-Ray Cassette

Synchroplan Corp., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827379 is the FDA 510(k) clearance record for X-RAY CASSETTE, cleared for Synchroplan Corp. on . FDA records list one 510(k) clearance for Synchroplan Corp. As of , FDA records show no recalls naming K827379.

Clearance record

Decision date
Received
(30 days to decision)
Review panel
Unknown
Applicant
Synchroplan Corp. 32 W. 40th St., New York NY
Third party review
No