BALLERT CRANIAL MOLDING HELMET— 510(k) K011433

Substantially Equivalent

Gema, Inc.

FDA 510(k) clearance K011433 for BALLERT CRANIAL MOLDING HELMET, Substantially Equivalent on 2001-06-12. Applicant: Gema, Inc.. Device class: 2.

Clearance details

Applicant: Gema, Inc.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2001-05-10
Decision date: 2001-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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.