K870257Substantially Equivalent

Porex(tm) Silicone Surgical Implants for e.n.t.

Name: K870257 Porex(tm) Silicone Surgical Implants for e.n.t.
Creator: Porex Medical
Published: 1987-02-24
License: https://open.fda.gov/license/

Porex Medical, Fairburn GA / Traditional, Substantially Equivalent

FDA source

K870257 is the FDA 510(k) clearance record for POREX(TM) SILICONE SURGICAL IMPLANTS FOR E.N.T., cleared for Porex Medical on 1987-02-24. FDA records list 15 510(k) clearances for Porex Medical, from 1983-06-24 to 1987-10-20. As of 2026-09-10, FDA records show no recalls naming K870257.

Clearance record

Decision date: 1987-02-24
Received: 1987-01-23 (32 days to decision)
Review panel: Unknown
Applicant: Porex Medical 500 Bohannon Rd., Fairburn GA
Third party review: No