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FDA 510(k)

HUMERAL FRACTURE CAST BRACE

K-Number: K811343 · 1981-05-28

ApplicantDeseret Medical, Inc.
Decision Date1981-05-28
Product CodeIQI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HUMERAL FRACTURE CAST BRACE is the device name listed in this FDA 510(k) record. The listed applicant is Deseret Medical, Inc.. It received FDA 510(k) clearance on 1981-05-28 under 510(k) number K811343. The device is classified under product code IQI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMERAL FRACTURE CAST BRACE?

HUMERAL FRACTURE CAST BRACE is a medical device that received FDA 510(k) clearance on 1981-05-28. The listed applicant is Deseret Medical, Inc.. The 510(k) number is K811343.

When did HUMERAL FRACTURE CAST BRACE receive FDA 510(k) clearance?

HUMERAL FRACTURE CAST BRACE received FDA 510(k) clearance on 1981-05-28, under 510(k) number K811343.

Who is the listed applicant for HUMERAL FRACTURE CAST BRACE?

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

What is the FDA product code for HUMERAL FRACTURE CAST BRACE?

The FDA product code for HUMERAL FRACTURE CAST BRACE is IQI.

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Other records listing Deseret Medical, 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.

K913027VESSEL DILATORK904648SAFE SYTE I.V. CATHETER PLACEMENT UNITK904121VIALON OBTURATORK904122INSYTE-A ARTERIAL CATHETERIZATION UNITK900116DESERET OPTIMA INTRAVASCULAR CATHETERK895735DESERET MULTILUMEN SUBCLAVIAN CATHETER

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Related Devices (Code: IQI)

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.

K052771SENSOR WALKOtto Bock Healthcare LPK031576SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1Surgitech, Inc.K926391ACCUFLEX DYNAMIC ELBOW ORTHOSISRegulatory & Marketing Services, Inc.K910974MCCONNELL SHOULDER BRACEMcconnell OrthopedicK874502GAIT-AID ORTHOPEDIC INSOLEGait-Aid, Inc.K831542ADJUSTABLE POLYCENTRIC ELBOW HINGEFred Sammons, 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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