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FDA 510(k)

TETRA NATAL-MAT WATER FLOTATION MAT.

K-Number: K802833 · 1980-12-10

ApplicantTetra Group U.S.A., Inc.
Decision Date1980-12-10
Product CodeIKY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TETRA NATAL-MAT WATER FLOTATION MAT. is the device name listed in this FDA 510(k) record. The listed applicant is Tetra Group U.S.A., Inc.. It received FDA 510(k) clearance on 1980-12-10 under 510(k) number K802833. 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 TETRA NATAL-MAT WATER FLOTATION MAT.?

TETRA NATAL-MAT WATER FLOTATION MAT. is a medical device that received FDA 510(k) clearance on 1980-12-10. The listed applicant is Tetra Group U.S.A., Inc.. The 510(k) number is K802833.

When did TETRA NATAL-MAT WATER FLOTATION MAT. receive FDA 510(k) clearance?

TETRA NATAL-MAT WATER FLOTATION MAT. received FDA 510(k) clearance on 1980-12-10, under 510(k) number K802833.

Who is the listed applicant for TETRA NATAL-MAT WATER FLOTATION MAT.?

The FDA 510(k) record lists Tetra Group U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TETRA NATAL-MAT WATER FLOTATION MAT.?

The FDA product code for TETRA NATAL-MAT WATER FLOTATION MAT. 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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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.K813226GEL FLOTATION MATTRESSJefferson Industries, 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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