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

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..

Clearance details

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

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