IVALON OPHTHALMIC SPONGE— 510(k) K946016

Substantially Equivalent

Ivalon

FDA 510(k) clearance K946016 for IVALON OPHTHALMIC SPONGE, Substantially Equivalent on 1995-03-22. Applicant: Ivalon. Device class: 2.

Clearance details

Applicant: Ivalon
Product code: Code HOZ
Device class: Class 2
Regulation: 21 CFR 886.4790
Advisory panel: Ophthalmic
Date received: 1994-12-09
Decision date: 1995-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ivalon

K946015 — IVALON EXTERNAL SPONGE1995-02-27
K913556 — IVALON EMBOLIZATION PARTICLES1994-04-13

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