510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K840090Substantially Equivalent

Vilene Surgical Mask 5505

Hall-Tech, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840090 is the FDA 510(k) clearance record for VILENE SURGICAL MASK 5505, cleared for Hall-Tech on . FDA records list 2 510(k) clearances for Hall-Tech, from to . As of , FDA records show no recalls naming K840090.

Clearance record

Decision date
Received
(106 days to decision)
Review panel
Unknown
Applicant
Hall-Tech 803 N. Front St. Suite 3, Mchenry IL
Third party review
No