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
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K861028Substantially Equivalent

Superlite Penlight

Keta Corp., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861028 is the FDA 510(k) clearance record for SUPERLITE PENLIGHT, cleared for Keta Corp. on . FDA records list 3 510(k) clearances for Keta Corp., from to . As of , FDA records show no recalls naming K861028.

Clearance record

Decision date
Received
(17 days to decision)
Review panel
Unknown
Applicant
Keta Corp. 9 Canal St., Danvers MA
Third party review
No