510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K827123Substantially Equivalent

Spectra (Ultraviolet Products)

Ultralite, Wheatridge CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827123 is the FDA 510(k) clearance record for SPECTRA (ULTRAVIOLET PRODUCTS), cleared for Ultralite on . FDA records list 6 510(k) clearances for Ultralite, from to . As of , FDA records show no recalls naming K827123.

Clearance record

Decision date
Received
(31 days to decision)
Review panel
Unknown
Applicant
Ultralite P.O.Box 5303, Wheatridge CO
Third party review
No