MOLDED CRANIAL HELMET— 510(k) K012920

Name: FDA 510(k) clearance K012920
Creator: U.S. Food and Drug Administration
Published: 2001-11-28

Substantially Equivalent

Fairview Orthopedic Laboratory

FDA 510(k) clearance K012920 for MOLDED CRANIAL HELMET, Substantially Equivalent on 2001-11-28. Applicant: Fairview Orthopedic Laboratory. Device class: 2.

Clearance details

Applicant: Fairview Orthopedic Laboratory
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2001-08-30
Decision date: 2001-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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