510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861292Substantially Equivalent

Castalert

Walgen Medical Innoventions, Syracuse NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861292 is the FDA 510(k) clearance record for CASTALERT, cleared for Walgen Medical Innoventions on . FDA records list 3 510(k) clearances for Walgen Medical Innoventions, from to . As of , FDA records show no recalls naming K861292.

Clearance record

Decision date
Received
(35 days to decision)
Review panel
Unknown
Applicant
Walgen Medical Innoventions 1201 E. Genesee St., Syracuse NY
Third party review
No