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
K812440Substantially Equivalent

Power Pack

Black & Decker(Tm), Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812440 is the FDA 510(k) clearance record for POWER PACK, cleared for Black & Decker(Tm) on . FDA records list 11 510(k) clearances for Black & Decker(Tm), from to . As of , FDA records show no recalls naming K812440.

Clearance record

Decision date
Received
(68 days to decision)
Review panel
Unknown
Applicant
Black & Decker(Tm) 803 N. Front St. Suite 3, Mchenry IL
Third party review
No