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FDA 510(k)

HANGER CRANIAL BAND

K-Number: K001669 · 2000-12-08

ApplicantHanger Orthopedic Group, Inc.
Decision Date2000-12-08
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HANGER CRANIAL BAND is the device name listed in this FDA 510(k) record. The listed applicant is Hanger Orthopedic Group, Inc.. It received FDA 510(k) clearance on 2000-12-08 under 510(k) number K001669. 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 HANGER CRANIAL BAND?

HANGER CRANIAL BAND is a medical device that received FDA 510(k) clearance on 2000-12-08. The listed applicant is Hanger Orthopedic Group, Inc.. The 510(k) number is K001669.

When did HANGER CRANIAL BAND receive FDA 510(k) clearance?

HANGER CRANIAL BAND received FDA 510(k) clearance on 2000-12-08, under 510(k) number K001669.

Who is the listed applicant for HANGER CRANIAL BAND?

The FDA 510(k) record lists Hanger Orthopedic Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HANGER CRANIAL BAND?

The FDA product code for HANGER CRANIAL BAND is MVA.

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Related Devices (Code: MVA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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