ACCUFLEX DYNAMIC ELBOW ORTHOSIS— 510(k) K926391

Name: FDA 510(k) clearance K926391
Creator: U.S. Food and Drug Administration
Published: 1993-07-22

Substantially Equivalent

Regulatory & Marketing Services, Inc.

FDA 510(k) clearance K926391 for ACCUFLEX DYNAMIC ELBOW ORTHOSIS, Substantially Equivalent on 1993-07-22. Applicant: Regulatory & Marketing Services, Inc.. Device class: 1.

Clearance details

Applicant: Regulatory & Marketing Services, Inc.
Product code: Code IQI
Device class: Class 1
Regulation: 21 CFR 890.3475
Advisory panel: Physical Medicine
Date received: 1992-12-21
Decision date: 1993-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Florida, FL, US

Download summary PDF View on FDA.gov ↗

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