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FDA 510(k)

SORBOTHANE

K-Number: K810228 · 1981-02-10

ApplicantHamilton Kent
Decision Date1981-02-10
Product CodeKNP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SORBOTHANE is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Kent. It received FDA 510(k) clearance on 1981-02-10 under 510(k) number K810228. The device is classified under product code KNP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SORBOTHANE?

SORBOTHANE is a medical device that received FDA 510(k) clearance on 1981-02-10. The listed applicant is Hamilton Kent. The 510(k) number is K810228.

When did SORBOTHANE receive FDA 510(k) clearance?

SORBOTHANE received FDA 510(k) clearance on 1981-02-10, under 510(k) number K810228.

Who is the listed applicant for SORBOTHANE?

The FDA 510(k) record lists Hamilton Kent as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SORBOTHANE?

The FDA product code for SORBOTHANE is KNP.

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.

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Related Devices (Code: KNP)

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.

K831690IPOS ANTI-ADDUCTUS SHOEIpos LuneburgK831552SORBOTHANE VISCO INNER SOLE PADFred Sammons, Inc.K823654SLIP-ON SANDALS FOR MEASURING SHORTNESSFred Sammons, Inc.K823665ROTATION BOOTWarm & Form, Orthopedic MaterialsK801743PLASTAZOTE SHOEAlimed, Inc.K790326DRUSHOEJ.E. Hanger & Co. , Ltd.

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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