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
K822529Substantially Equivalent

Special Eye Mirror

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

K822529 is the FDA 510(k) clearance record for SPECIAL EYE MIRROR, cleared for Wilmington Optics, Inc. on . FDA records list one 510(k) clearance for Wilmington Optics, Inc. As of , FDA records show no recalls naming K822529.

Clearance record

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