LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET— 510(k) K023572

Name: FDA 510(k) clearance K023572
Creator: U.S. Food and Drug Administration
Published: 2003-01-13

Substantially Equivalent

Rehabilitation Institute,Loma Linda University Med

FDA 510(k) clearance K023572 for LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET, Substantially Equivalent on 2003-01-13. Applicant: Rehabilitation Institute,Loma Linda University Med. Device class: 2.

Clearance details

Applicant: Rehabilitation Institute,Loma Linda University Med
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2002-10-24
Decision date: 2003-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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