510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861800Substantially Equivalent for Some Indications

Waxtreat B

Beaute Naturelle International, Inc., Mcallen TX / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K861800 is the FDA 510(k) clearance record for WAXTREAT B, cleared for Beaute Naturelle International, Inc. on . FDA records list 3 510(k) clearances for Beaute Naturelle International, Inc., from to . As of , FDA records show no recalls naming K861800.

Clearance record

Decision date
Received
(39 days to decision)
Review panel
Unknown
Applicant
Beaute Naturelle International, Inc. 1122 N. Tenth St., Mcallen TX
Third party review
No