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FDA 510(k)

PROVIDENCE MOLDING HELMET

K-Number: K030669 · 2003-07-18

ApplicantNortheast Orthotics and Prothetics, Inc.
Decision Date2003-07-18
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PROVIDENCE MOLDING HELMET is the device name listed in this FDA 510(k) record. The listed applicant is Northeast Orthotics and Prothetics, Inc.. It received FDA 510(k) clearance on 2003-07-18 under 510(k) number K030669. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROVIDENCE MOLDING HELMET?

PROVIDENCE MOLDING HELMET is a medical device that received FDA 510(k) clearance on 2003-07-18. The listed applicant is Northeast Orthotics and Prothetics, Inc.. The 510(k) number is K030669.

When did PROVIDENCE MOLDING HELMET receive FDA 510(k) clearance?

PROVIDENCE MOLDING HELMET received FDA 510(k) clearance on 2003-07-18, under 510(k) number K030669.

Who is the listed applicant for PROVIDENCE MOLDING HELMET?

The FDA 510(k) record lists Northeast Orthotics and Prothetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROVIDENCE MOLDING HELMET?

The FDA product code for PROVIDENCE MOLDING HELMET is MVA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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