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
K831794Substantially Equivalent

Sets & Trays

I M, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831794 is the FDA 510(k) clearance record for SETS & TRAYS, cleared for I M, Inc. on . FDA records list 26 510(k) clearances for I M, Inc., from to . As of , FDA records show no recalls naming K831794.

Clearance record

Decision date
Received
(74 days to decision)
Review panel
Unknown
Applicant
I M, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No