510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K854140Substantially Equivalent

Modified Mydriatic Spectacle

La Rue Optical, Dover PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854140 is the FDA 510(k) clearance record for MODIFIED MYDRIATIC SPECTACLE, cleared for La Rue Optical on . FDA records list one 510(k) clearance for La Rue Optical. As of , FDA records show no recalls naming K854140.

Clearance record

Decision date
Received
(68 days to decision)
Review panel
Unknown
Applicant
La Rue Optical Industrial Park, Dover PA
Third party review
No