510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800845Substantially Equivalent

Bronzage Tanning System

Bronzage Rapide, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800845 is the FDA 510(k) clearance record for BRONZAGE TANNING SYSTEM, cleared for Bronzage Rapide on . FDA records list one 510(k) clearance for Bronzage Rapide. As of , FDA records show no recalls naming K800845.

Clearance record

Decision date
Received
(63 days to decision)
Review panel
Unknown
Applicant
Bronzage Rapide 803 N. Front St. Suite 3, Mchenry IL
Third party review
No