FDA 510(k)

ROSEBUD DISSECTOR

K-Number: K945332 · 1994-12-05

Decision Date1994-12-05

Product CodeGDY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ROSEBUD DISSECTOR 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 1994-12-05 under 510(k) number K945332. 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 ROSEBUD DISSECTOR?

ROSEBUD DISSECTOR is a medical device that received FDA 510(k) clearance on 1994-12-05. The listed applicant is Lorrex Health Products. The 510(k) number is K945332.

When did ROSEBUD DISSECTOR receive FDA 510(k) clearance?

ROSEBUD DISSECTOR received FDA 510(k) clearance on 1994-12-05, under 510(k) number K945332.

Who is the listed applicant for ROSEBUD DISSECTOR?

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 ROSEBUD DISSECTOR?

The FDA product code for ROSEBUD DISSECTOR is GDY.

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Other records listing Lorrex Health Products as applicant

K945335CHERRY DISSECTOR K945866CYLINDRICAL SPONGE K945553ROUND STICK SPONGES, FLAT STICK SPONGES K945606TRIANGULAR SPONGES K945333KITTNER DISSECTOR K945334CHERRY PIT DISSECTOR

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Related Devices (Code: GDY)

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack Reliability K955599STRYKER 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.