LERMAN & SON CRANIAL ORTHOSIS HELMET— 510(k) K012830

Name: FDA 510(k) clearance K012830
Creator: U.S. Food and Drug Administration
Published: 2001-11-20

Substantially Equivalent

Lerman & Son

FDA 510(k) clearance K012830 for LERMAN & SON CRANIAL ORTHOSIS HELMET, Substantially Equivalent on 2001-11-20. Applicant: Lerman & Son. Device class: 2.

Clearance details

Applicant: Lerman & Son
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2001-08-23
Decision date: 2001-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly Hills, CA, 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.