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FDA 510(k)

STARBAND CRANIAL ORTHOSIS

K-Number: K011350 · 2001-07-03

ApplicantOrthomerica Products, Inc.
Decision Date2001-07-03
Product CodeOAN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STARBAND CRANIAL ORTHOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Orthomerica Products, Inc.. It received FDA 510(k) clearance on 2001-07-03 under 510(k) number K011350. 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 STARBAND CRANIAL ORTHOSIS?

STARBAND CRANIAL ORTHOSIS is a medical device that received FDA 510(k) clearance on 2001-07-03. The listed applicant is Orthomerica Products, Inc.. The 510(k) number is K011350.

When did STARBAND CRANIAL ORTHOSIS receive FDA 510(k) clearance?

STARBAND CRANIAL ORTHOSIS received FDA 510(k) clearance on 2001-07-03, under 510(k) number K011350.

Who is the listed applicant for STARBAND CRANIAL ORTHOSIS?

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

What is the FDA product code for STARBAND CRANIAL ORTHOSIS?

The FDA product code for STARBAND CRANIAL ORTHOSIS is OAN.

Related Clinical Trials

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Other records listing Orthomerica Products, Inc. as applicant

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.

K240466STARband 3DK223238STARband 3DK211376STARbandK203098STARband, STARlight, St. Louis BandK180109STARband, STARlight, St. Louis BandK161138St. Louis Band

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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.

K244056DOC Band 3DCranial Technologies, Inc.K240466STARband 3DOrthomerica Products, Inc.K211376STARbandOrthomerica Products, Inc.K203098STARband, STARlight, St. Louis BandOrthomerica Products, Inc.K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.K161138St. Louis BandOrthomerica Products, Inc.

Official Source

View on FDA Database →

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

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