CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS— 510(k) K812422

Name: FDA 510(k) clearance K812422
Creator: U.S. Food and Drug Administration
Published: 1981-09-14

Substantially Equivalent

Surgical Appliance Industries, Inc.

FDA 510(k) clearance K812422 for CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS, Substantially Equivalent on 1981-09-14. Applicant: Surgical Appliance Industries, Inc.. Device class: 1.

Clearance details

Applicant: Surgical Appliance Industries, Inc.
Product code: Code IPY
Device class: Class 1
Regulation: 21 CFR 890.3490
Advisory panel: Physical Medicine
Date received: 1981-08-24
Decision date: 1981-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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