CRANIAL MOLDING ORTHOSIS— 510(k) K010273

Name: FDA 510(k) clearance K010273
Creator: U.S. Food and Drug Administration
Published: 2001-04-25

Substantially Equivalent

Orthotic Solutions, Inc.

FDA 510(k) clearance K010273 for CRANIAL MOLDING ORTHOSIS, Substantially Equivalent on 2001-04-25. Applicant: Orthotic Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Orthotic Solutions, Inc.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2001-01-29
Decision date: 2001-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfax, VA, US

Download summary PDF View on FDA.gov ↗

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