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FDA 510(k)

ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES

K-Number: K865095 · 1987-01-20

ApplicantKor-Medical Industries, Ltd.
Decision Date1987-01-20
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES is the device name listed in this FDA 510(k) record. The listed applicant is Kor-Medical Industries, Ltd.. It received FDA 510(k) clearance on 1987-01-20 under 510(k) number K865095. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES?

ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES is a medical device that received FDA 510(k) clearance on 1987-01-20. The listed applicant is Kor-Medical Industries, Ltd.. The 510(k) number is K865095.

When did ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES receive FDA 510(k) clearance?

ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES received FDA 510(k) clearance on 1987-01-20, under 510(k) number K865095.

Who is the listed applicant for ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES?

The FDA 510(k) record lists Kor-Medical Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES?

The FDA product code for ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES is EFQ.

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 Kor-Medical Industries, Ltd. 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.

K865097AIMED GAUZE SPONGE

Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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