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FDA 510(k)

LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILE

K-Number: K942692 · 1994-08-03

ApplicantLorons International Corp.
Decision Date1994-08-03
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Lorons International Corp.. It received FDA 510(k) clearance on 1994-08-03 under 510(k) number K942692. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILE?

LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILE is a medical device that received FDA 510(k) clearance on 1994-08-03. The listed applicant is Lorons International Corp.. The 510(k) number is K942692.

When did LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILE receive FDA 510(k) clearance?

LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILE received FDA 510(k) clearance on 1994-08-03, under 510(k) number K942692.

Who is the listed applicant for LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILE?

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

What is the FDA product code for LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILE?

The FDA product code for LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILE is EFQ.

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Other records listing Lorons International Corp. 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.

K951418LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILEK945960LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGSK943184LORREX HEALTH PROD COTTON FILLED SPONGES STERILE 2'SK942691LORREX POST OPERATIVE SPONGESK941956LORREX GAUZE PADS

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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