URETHANE ORTHOPAEDIC CASTING TAPE— 510(k) K811164

Name: FDA 510(k) clearance K811164
Creator: U.S. Food and Drug Administration
Published: 1981-05-27

Substantially Equivalent

Hexcel Medical

FDA 510(k) clearance K811164 for URETHANE ORTHOPAEDIC CASTING TAPE, Substantially Equivalent on 1981-05-27. Applicant: Hexcel Medical. Device class: 1.

Clearance details

Applicant: Hexcel Medical
Product code: Code ITG
Device class: Class 1
Regulation: 21 CFR 890.3025
Advisory panel: Physical Medicine
Date received: 1981-04-28
Decision date: 1981-05-27
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.