ULTRACAST WATERLESS SYNTHETIC RESIN CAST— 510(k) K813052

Name: FDA 510(k) clearance K813052
Creator: U.S. Food and Drug Administration
Published: 1982-02-04

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K813052 for ULTRACAST WATERLESS SYNTHETIC RESIN CAST, Substantially Equivalent on 1982-02-04. Applicant: Zimmer, Inc.. Device class: 1.

Clearance details

Applicant: Zimmer, Inc.
Product code: Product code ITG
Device class: Class 1
Regulation: 21 CFR 890.3025
Advisory panel: Physical Medicine
Date received: 1981-10-29
Decision date: 1982-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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