BECKER BAND CRANIAL REMOLDING ORTHOSIS— 510(k) K013719

Name: FDA 510(k) clearance K013719
Creator: U.S. Food and Drug Administration
Published: 2002-02-05

Substantially Equivalent

Becker Orthopedic Appliance Co.

FDA 510(k) clearance K013719 for BECKER BAND CRANIAL REMOLDING ORTHOSIS, Substantially Equivalent on 2002-02-05. Applicant: Becker Orthopedic Appliance Co.. Device class: 2.

Clearance details

Applicant: Becker Orthopedic Appliance Co.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2001-11-08
Decision date: 2002-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, MI, US

Download summary PDF View on FDA.gov ↗

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