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FDA 510(k)

SCM-3 AND ACCESSORIES

K-Number: K914921 · 1992-03-12

ApplicantGaymar Industries, Inc.
Decision Date1992-03-12
Product CodeIKY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SCM-3 AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Gaymar Industries, Inc.. It received FDA 510(k) clearance on 1992-03-12 under 510(k) number K914921. 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 SCM-3 AND ACCESSORIES?

SCM-3 AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1992-03-12. The listed applicant is Gaymar Industries, Inc.. The 510(k) number is K914921.

When did SCM-3 AND ACCESSORIES receive FDA 510(k) clearance?

SCM-3 AND ACCESSORIES received FDA 510(k) clearance on 1992-03-12, under 510(k) number K914921.

Who is the listed applicant for SCM-3 AND ACCESSORIES?

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

What is the FDA product code for SCM-3 AND ACCESSORIES?

The FDA product code for SCM-3 AND ACCESSORIES is IKY.

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Other records listing Gaymar Industries, Inc. as applicant

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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.

K813226GEL FLOTATION MATTRESSJefferson 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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