510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K863239Substantially Equivalent

Fasciculated Boat Rod

The Deca Co., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863239 is the FDA 510(k) clearance record for FASCICULATED BOAT ROD, cleared for The Deca Co. on . FDA records list 7 510(k) clearances for The Deca Co., from to . As of , FDA records show no recalls naming K863239.

Clearance record

Decision date
Received
(124 days to decision)
Review panel
Unknown
Applicant
The Deca Co. P.O. Box 1997, Costa Mesa CA
Third party review
No