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
K810400Substantially Equivalent

Glycerine Dehydration Unit

Xytex Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810400 is the FDA 510(k) clearance record for GLYCERINE DEHYDRATION UNIT, cleared for Xytex Corp. on . FDA records list one 510(k) clearance for Xytex Corp. As of , FDA records show no recalls naming K810400.

Clearance record

Decision date
Received
(188 days to decision)
Review panel
Unknown
Applicant
Xytex Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No