O&P CRANICAL MOLDING HELMET— 510(k) K021221

Name: FDA 510(k) clearance K021221
Creator: U.S. Food and Drug Administration
Published: 2002-07-01

Substantially Equivalent

Orthotic & Prosthetic Lab, Inc.

FDA 510(k) clearance K021221 for O&P CRANICAL MOLDING HELMET, Substantially Equivalent on 2002-07-01. Applicant: Orthotic & Prosthetic Lab, Inc.. Device class: 2.

Clearance details

Applicant: Orthotic & Prosthetic Lab, Inc.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2002-04-17
Decision date: 2002-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster Groves, MO, US

Download summary PDF View on FDA.gov ↗

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