O&P BIVALVE CRANIAL MOLDING HELMET— 510(k) K063395

Substantially Equivalent

Orthotic & Prosthetic Lab, Inc.

FDA 510(k) clearance K063395 for O&P BIVALVE CRANIAL MOLDING HELMET, Substantially Equivalent on 2006-12-22. Applicant: Orthotic & Prosthetic Lab, Inc..

Clearance details

Applicant: Orthotic & Prosthetic Lab, Inc.
Product code: Code MVA
Advisory panel: Neurology
Date received: 2006-11-09
Decision date: 2006-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster Groves, MO, US

Download summary PDF View on FDA.gov ↗

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