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
K842879Substantially Equivalent

Alphacoil

Japan Para Science Institute, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842879 is the FDA 510(k) clearance record for ALPHACOIL, cleared for Japan Para Science Institute on . FDA records list one 510(k) clearance for Japan Para Science Institute. As of , FDA records show no recalls naming K842879.

Clearance record

Decision date
Received
(18 days to decision)
Review panel
Unknown
Applicant
Japan Para Science Institute 803 N. Front St. Suite 3, Mchenry IL
Third party review
No