IVALON EXTERNAL SPONGE— 510(k) K946015

Substantially Equivalent

Ivalon

FDA 510(k) clearance K946015 for IVALON EXTERNAL SPONGE, Substantially Equivalent on 1995-02-27. Applicant: Ivalon. Device class: 1.

Clearance details

Applicant: Ivalon
Product code: Code NAB
Device class: Class 1
Regulation: 21 CFR 878.4014
Advisory panel: General, Plastic Surgery
Date received: 1994-12-09
Decision date: 1995-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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More clearances from Ivalon

K946016 — IVALON OPHTHALMIC SPONGE1995-03-22
K913556 — IVALON EMBOLIZATION PARTICLES1994-04-13

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