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FDA 510(k)

ROUND STICK SPONGES, FLAT STICK SPONGES

K-Number: K945553 · 1994-12-28

ApplicantLorrex Health Products
Decision Date1994-12-28
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ROUND STICK SPONGES, FLAT STICK 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 1994-12-28 under 510(k) number K945553. 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 ROUND STICK SPONGES, FLAT STICK SPONGES?

ROUND STICK SPONGES, FLAT STICK SPONGES is a medical device that received FDA 510(k) clearance on 1994-12-28. The listed applicant is Lorrex Health Products. The 510(k) number is K945553.

When did ROUND STICK SPONGES, FLAT STICK SPONGES receive FDA 510(k) clearance?

ROUND STICK SPONGES, FLAT STICK SPONGES received FDA 510(k) clearance on 1994-12-28, under 510(k) number K945553.

Who is the listed applicant for ROUND STICK SPONGES, FLAT STICK 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 ROUND STICK SPONGES, FLAT STICK SPONGES?

The FDA product code for ROUND STICK SPONGES, FLAT STICK SPONGES 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 SPONGEK945606TRIANGULAR SPONGESK945333KITTNER DISSECTORK945334CHERRY PIT DISSECTORK945336PEANUT 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.K953058ROUND STICK SPONGES, FLAT STICK SPONGESMedical 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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