SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1— 510(k) K031576

Name: FDA 510(k) clearance K031576
Creator: U.S. Food and Drug Administration
Published: 2003-07-31

Substantially Equivalent

Surgitech, Inc.

FDA 510(k) clearance K031576 for SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1, Substantially Equivalent on 2003-07-31. Applicant: Surgitech, Inc.. Device class: 1.

Clearance details

Applicant: Surgitech, Inc.
Product code: Code IQI
Device class: Class 1
Regulation: 21 CFR 890.3475
Advisory panel: Physical Medicine
Date received: 2003-05-20
Decision date: 2003-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oceanside, CA, US

Download summary PDF View on FDA.gov ↗

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