STATIC CRANIOPLASTY ORTHOSIS— 510(k) K020448

Name: FDA 510(k) clearance K020448
Creator: U.S. Food and Drug Administration
Published: 2002-04-12

Substantially Equivalent

Eastern Cranial Affiliates

FDA 510(k) clearance K020448 for STATIC CRANIOPLASTY ORTHOSIS, Substantially Equivalent on 2002-04-12. Applicant: Eastern Cranial Affiliates. Device class: 2.

Clearance details

Applicant: Eastern Cranial Affiliates
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2002-02-11
Decision date: 2002-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, VA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.