PROVIDENCE MOLDING HELMET— 510(k) K030669

Name: FDA 510(k) clearance K030669
Creator: U.S. Food and Drug Administration
Published: 2003-07-18

Substantially Equivalent

Northeast Orthotics and Prothetics, Inc.

FDA 510(k) clearance K030669 for PROVIDENCE MOLDING HELMET, Substantially Equivalent on 2003-07-18. Applicant: Northeast Orthotics and Prothetics, Inc.. Device class: 2.

Clearance details

Applicant: Northeast Orthotics and Prothetics, Inc.
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2003-03-03
Decision date: 2003-07-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Cranston, RI, US

Download summary PDF View on FDA.gov ↗

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