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FDA 510(k)

ORTHOSIS HELMET MOLDING

K-Number: K013700 · 2002-02-05

ApplicantPrecision Prosthetics & Orthotics, Inc.
Decision Date2002-02-05
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ORTHOSIS HELMET MOLDING is the device name listed in this FDA 510(k) record. The listed applicant is Precision Prosthetics & Orthotics, Inc.. It received FDA 510(k) clearance on 2002-02-05 under 510(k) number K013700. 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 ORTHOSIS HELMET MOLDING?

ORTHOSIS HELMET MOLDING is a medical device that received FDA 510(k) clearance on 2002-02-05. The listed applicant is Precision Prosthetics & Orthotics, Inc.. The 510(k) number is K013700.

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

ORTHOSIS HELMET MOLDING received FDA 510(k) clearance on 2002-02-05, under 510(k) number K013700.

Who is the listed applicant for ORTHOSIS HELMET MOLDING?

The FDA 510(k) record lists Precision Prosthetics & Orthotics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHOSIS HELMET MOLDING?

The FDA product code for ORTHOSIS HELMET MOLDING is MVA.

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Related Devices (Code: 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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