POREX(TM) EYE SPHERE IMPLANT— 510(k) K863943

Substantially Equivalent

Porex Medical

FDA 510(k) clearance K863943 for POREX(TM) EYE SPHERE IMPLANT, Substantially Equivalent on 1987-02-27. Applicant: Porex Medical. Device class: 2.

Clearance details

Applicant: Porex Medical
Product code: Code HPZ
Device class: Class 2
Regulation: 21 CFR 886.3320
Advisory panel: Ophthalmic
Date received: 1986-10-10
Decision date: 1987-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairburn, GA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Porex Medical

K872791 — POREX NERVE LOCATOR1987-10-20
K873044 — POREX OTOLOGY INSTRUMENTS1987-09-04
K872947 — POREX QUALITY PLASTIC SURGERY INSTRUMENTS1987-08-21
K863946 — POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT1987-02-27
K870154 — POREX(TM) TISSUE EXPANDER1987-02-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.