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FDA 510(k)

LORREX GAUZE SPONGES, X-RAY DETECTABLE

K-Number: K942366 · 1994-05-27

ApplicantLorrex Health Products
Decision Date1994-05-27
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LORREX GAUZE SPONGES, X-RAY DETECTABLE 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 1994-05-27 under 510(k) number K942366. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LORREX GAUZE SPONGES, X-RAY DETECTABLE?

LORREX GAUZE SPONGES, X-RAY DETECTABLE is a medical device that received FDA 510(k) clearance on 1994-05-27. The listed applicant is Lorrex Health Products. The 510(k) number is K942366.

When did LORREX GAUZE SPONGES, X-RAY DETECTABLE receive FDA 510(k) clearance?

LORREX GAUZE SPONGES, X-RAY DETECTABLE received FDA 510(k) clearance on 1994-05-27, under 510(k) number K942366.

Who is the listed applicant for LORREX GAUZE SPONGES, X-RAY DETECTABLE?

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 LORREX GAUZE SPONGES, X-RAY DETECTABLE?

The FDA product code for LORREX GAUZE SPONGES, X-RAY DETECTABLE is GDY.

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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: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953059KITTNER DISSECTORMedical Perspectives Corp.

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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