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FDA 510(k)

CLOTH-HYPOALLERGENIC

K-Number: K840947 · 1984-08-17

ApplicantGainor Medical
Decision Date1984-08-17
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLOTH-HYPOALLERGENIC is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical. It received FDA 510(k) clearance on 1984-08-17 under 510(k) number K840947. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLOTH-HYPOALLERGENIC?

CLOTH-HYPOALLERGENIC is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is Gainor Medical. The 510(k) number is K840947.

When did CLOTH-HYPOALLERGENIC receive FDA 510(k) clearance?

CLOTH-HYPOALLERGENIC received FDA 510(k) clearance on 1984-08-17, under 510(k) number K840947.

Who is the listed applicant for CLOTH-HYPOALLERGENIC?

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

What is the FDA product code for CLOTH-HYPOALLERGENIC?

The FDA product code for CLOTH-HYPOALLERGENIC is KGX.

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Other records listing Gainor Medical 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.

K850100BLOOD LANCETK850150ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MEDK844306GAINOR MEDICAL SYRINGEK844305GAINOR MEDICAL FLOWMAX NEEDLESK840945SKIN CLOSUREK840950ZINC OXIDE TAPE

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Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, 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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