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FDA 510(k)

HANGER CRANIAL BAND

K-Number: K072566 · 2008-01-09

Decision Date2008-01-09
Product CodeOAN
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 Prosthetics & Orthotics, Inc.. It received FDA 510(k) clearance on 2008-01-09 under 510(k) number K072566. The device is classified under product code OAN. 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 2008-01-09. The listed applicant is Hanger Prosthetics & Orthotics, Inc.. The 510(k) number is K072566.

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

HANGER CRANIAL BAND received FDA 510(k) clearance on 2008-01-09, under 510(k) number K072566.

Who is the listed applicant for HANGER CRANIAL BAND?

The FDA 510(k) record lists Hanger Prosthetics & Orthotics, 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 OAN.

Related Clinical Trials

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.

Related Devices (Code: OAN)

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.

Official Source

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