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FDA 510(k)

FIRST AID BANDAGE

K-Number: K840951 · 1984-10-31

ApplicantGainor Medical
Decision Date1984-10-31
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FIRST AID BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical. It received FDA 510(k) clearance on 1984-10-31 under 510(k) number K840951. 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 FIRST AID BANDAGE?

FIRST AID BANDAGE is a medical device that received FDA 510(k) clearance on 1984-10-31. The listed applicant is Gainor Medical. The 510(k) number is K840951.

When did FIRST AID BANDAGE receive FDA 510(k) clearance?

FIRST AID BANDAGE received FDA 510(k) clearance on 1984-10-31, under 510(k) number K840951.

Who is the listed applicant for FIRST AID BANDAGE?

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 FIRST AID BANDAGE?

The FDA product code for FIRST AID BANDAGE 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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