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FDA 510(k)

SUPER/FLUFF SPONGES

K-Number: K942106 · 1994-05-19

ApplicantLorrex Health Products
Decision Date1994-05-19
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

SUPER/FLUFF SPONGES 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 1994-05-19 under 510(k) number K942106. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPER/FLUFF SPONGES?

SUPER/FLUFF SPONGES is a medical device that received FDA 510(k) clearance on 1994-05-19. The listed applicant is Lorrex Health Products. The 510(k) number is K942106.

When did SUPER/FLUFF SPONGES receive FDA 510(k) clearance?

SUPER/FLUFF SPONGES received FDA 510(k) clearance on 1994-05-19, under 510(k) number K942106.

Who is the listed applicant for SUPER/FLUFF SPONGES?

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 SUPER/FLUFF SPONGES?

The FDA product code for SUPER/FLUFF SPONGES 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

View all 16 devices →

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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