510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862367Substantially Equivalent

Pro-Clean

Dermacare Products, Inc., Louisville KT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862367 is the FDA 510(k) clearance record for PRO-CLEAN, cleared for Dermacare Products, Inc. on . FDA records list 8 510(k) clearances for Dermacare Products, Inc., from to . As of , FDA records show no recalls naming K862367.

Clearance record

Decision date
Received
(14 days to decision)
Review panel
Unknown
Applicant
Dermacare Products, Inc. 7651 National Tpke., Louisville KT
Third party review
No