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FDA 510(k)

GEL FLOTATION MATTRESS

K-Number: K813226 · 1981-12-02

ApplicantJefferson Industries, Inc.
Decision Date1981-12-02
Product CodeIKY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GEL FLOTATION MATTRESS is the device name listed in this FDA 510(k) record. The listed applicant is Jefferson Industries, Inc.. It received FDA 510(k) clearance on 1981-12-02 under 510(k) number K813226. The device is classified under product code IKY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEL FLOTATION MATTRESS?

GEL FLOTATION MATTRESS is a medical device that received FDA 510(k) clearance on 1981-12-02. The listed applicant is Jefferson Industries, Inc.. The 510(k) number is K813226.

When did GEL FLOTATION MATTRESS receive FDA 510(k) clearance?

GEL FLOTATION MATTRESS received FDA 510(k) clearance on 1981-12-02, under 510(k) number K813226.

Who is the listed applicant for GEL FLOTATION MATTRESS?

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

What is the FDA product code for GEL FLOTATION MATTRESS?

The FDA product code for GEL FLOTATION MATTRESS is IKY.

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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Other records listing Jefferson Industries, 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.

K813225GEL FLOTATION CUSHIONK802603ECONO-FLOAT WHEELCHAIR FLOTATION CUSHIONK780779ECONO-FLOAT WATER FLOTATION MATTRESS

Related Devices (Code: IKY)

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.

K914921SCM-3 AND ACCESSORIESGaymar Industries, Inc.K802833TETRA NATAL-MAT WATER FLOTATION MAT.Tetra Group U.S.A., Inc.K802781BEDDING PADS EGGCREATE PADSLeemart Bedding Mfg. Co.K780779ECONO-FLOAT WATER FLOTATION MATTRESSJefferson Industries, Inc.K772062NEONATAL FLOTATION SYSTEMMedpro, Inc.K771824MEDPRO FLOTATION SYSTEMMedpro, 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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