LUMBOSACRAL SUPPORT— 510(k) K823823

Substantially Equivalent

Danek Medical, Inc.

FDA 510(k) clearance K823823 for LUMBOSACRAL SUPPORT, Substantially Equivalent on 1983-01-14. Applicant: Danek Medical, Inc.. Device class: 1.

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code IPY
Device class: Class 1
Regulation: 21 CFR 890.3490
Advisory panel: Physical Medicine
Date received: 1982-12-17
Decision date: 1983-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K811494 — LUMBO-SACRAL FLEXION ORTHOSIS1981-06-16
K810554 — LUMBAR FLEXION BRACE1981-03-13

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