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FDA 510(k)

LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S

K-Number: K941955 · 1994-05-12

ApplicantLorrex Health Products
Decision Date1994-05-12
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S is the device name listed in this FDA 510(k) record. The listed applicant is Lorrex Health Products. It received FDA 510(k) clearance on 1994-05-12 under 510(k) number K941955. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S?

LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S is a medical device that received FDA 510(k) clearance on 1994-05-12. The listed applicant is Lorrex Health Products. The 510(k) number is K941955.

When did LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S receive FDA 510(k) clearance?

LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S received FDA 510(k) clearance on 1994-05-12, under 510(k) number K941955.

Who is the listed applicant for LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S?

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

What is the FDA product code for LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S?

The FDA product code for LOREX TRACHEOSTOMY GAUZE SPONGES - STERILE 1'S AND 2'S is EFQ.

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Other records listing Lorrex Health Products 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.

K945335CHERRY DISSECTORK945866CYLINDRICAL SPONGEK945553ROUND STICK SPONGES, FLAT STICK SPONGESK945606TRIANGULAR SPONGESK945333KITTNER DISSECTORK945334CHERRY PIT DISSECTOR

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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

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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