510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870182Substantially Equivalent

Porex(tm) Malar Implant

Porex Medical, Fairburn GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870182 is the FDA 510(k) clearance record for POREX(TM) MALAR IMPLANT, cleared for Porex Medical on . FDA records list 15 510(k) clearances for Porex Medical, from to . As of , FDA records show no recalls naming K870182.

Clearance record

Decision date
Received
(39 days to decision)
Review panel
Unknown
Applicant
Porex Medical 500 Bohannon Rd., Fairburn GA
Third party review
No