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FDA 510(k)

PLASTAZOTE SHOE

K-Number: K801743 · 1980-08-07

ApplicantAlimed, Inc.
Decision Date1980-08-07
Product CodeKNP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PLASTAZOTE SHOE is the device name listed in this FDA 510(k) record. The listed applicant is Alimed, Inc.. It received FDA 510(k) clearance on 1980-08-07 under 510(k) number K801743. 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 PLASTAZOTE SHOE?

PLASTAZOTE SHOE is a medical device that received FDA 510(k) clearance on 1980-08-07. The listed applicant is Alimed, Inc.. The 510(k) number is K801743.

When did PLASTAZOTE SHOE receive FDA 510(k) clearance?

PLASTAZOTE SHOE received FDA 510(k) clearance on 1980-08-07, under 510(k) number K801743.

Who is the listed applicant for PLASTAZOTE SHOE?

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

What is the FDA product code for PLASTAZOTE SHOE?

The FDA product code for PLASTAZOTE SHOE is KNP.

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Other records listing Alimed, 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.

K963527UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPSK963528ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)K963526STRAP WEDGEK920487MINI VIBRATORK840156PROTECTA COAT SPONGESK822650SUPER DONUT

View all 11 devices →

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 MaterialsK810228SORBOTHANEHamilton KentK790326DRUSHOEJ.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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