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FDA 510(k)

LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS

K-Number: K945960 · 1995-01-12

ApplicantLorons International Corp.
Decision Date1995-01-12
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS 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 1995-01-12 under 510(k) number K945960. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS?

LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS is a medical device that received FDA 510(k) clearance on 1995-01-12. The listed applicant is Lorons International Corp.. The 510(k) number is K945960.

When did LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS receive FDA 510(k) clearance?

LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS received FDA 510(k) clearance on 1995-01-12, under 510(k) number K945960.

Who is the listed applicant for LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS?

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 NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS?

The FDA product code for LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS is EFQ.

Related Clinical Trials

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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-STERILEK943184LORREX HEALTH PROD COTTON FILLED SPONGES STERILE 2'SK942692LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILEK942691LORREX 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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