DYNAMIC EXTENSOR SPLINT— 510(k) K800143

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K800143 for DYNAMIC EXTENSOR SPLINT, Substantially Equivalent on 1980-02-19. Applicant: Biomet, Inc.. Device class: 1.

Clearance details

Applicant: Biomet, Inc.
Product code: Code ILH
Device class: Class 1
Regulation: 21 CFR 890.3475
Advisory panel: Physical Medicine
Date received: 1980-01-21
Decision date: 1980-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K823666 — UNIVERSAL WRIST SPLINT & FOREARM SPLINT1982-12-30

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