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FDA 510(k)

ACRYLIC HERBST SPLINT APPLIANCE

K-Number: K083209 · 2009-01-27

ApplicantSpecialty Appliance Works, Inc.
Decision Date2009-01-27
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACRYLIC HERBST SPLINT APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Appliance Works, Inc.. It received FDA 510(k) clearance on 2009-01-27 under 510(k) number K083209. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACRYLIC HERBST SPLINT APPLIANCE?

ACRYLIC HERBST SPLINT APPLIANCE is a medical device that received FDA 510(k) clearance on 2009-01-27. The listed applicant is Specialty Appliance Works, Inc.. The 510(k) number is K083209.

When did ACRYLIC HERBST SPLINT APPLIANCE receive FDA 510(k) clearance?

ACRYLIC HERBST SPLINT APPLIANCE received FDA 510(k) clearance on 2009-01-27, under 510(k) number K083209.

Who is the listed applicant for ACRYLIC HERBST SPLINT APPLIANCE?

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

What is the FDA product code for ACRYLIC HERBST SPLINT APPLIANCE?

The FDA product code for ACRYLIC HERBST SPLINT APPLIANCE is LRK.

Related Clinical Trials

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Other records listing Specialty Appliance Works, 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.

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Related Devices (Code: LRK)

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

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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