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FDA 510(k)

URO TEX URINALS

K-Number: K901000 · 1990-03-26

ApplicantSierra Laboratories, Inc.
Decision Date1990-03-26
Product CodeEYZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URO TEX URINALS is the device name listed in this FDA 510(k) record. The listed applicant is Sierra Laboratories, Inc.. It received FDA 510(k) clearance on 1990-03-26 under 510(k) number K901000. The device is classified under product code EYZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URO TEX URINALS?

URO TEX URINALS is a medical device that received FDA 510(k) clearance on 1990-03-26. The listed applicant is Sierra Laboratories, Inc.. The 510(k) number is K901000.

When did URO TEX URINALS receive FDA 510(k) clearance?

URO TEX URINALS received FDA 510(k) clearance on 1990-03-26, under 510(k) number K901000.

Who is the listed applicant for URO TEX URINALS?

The FDA 510(k) record lists Sierra Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URO TEX URINALS?

The FDA product code for URO TEX URINALS is EYZ.

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Other records listing Sierra Laboratories, Inc. as applicant

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Related Devices (Code: EYZ)

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.

K964219ZIP CONDOM CATHETERGoulter Medical, Inc.K961906UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018Spectrum Medsystems Corp.K952780URINARY GEL DRAINAGE SYSTEMP.A.M., Inc.K951597URINARY DRAINAGE BAGKey Medical Services, Inc.K942753ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINERResearched, Novel Medical Devices (Rn/Md)K933126COMFORTCARE SYSTEMPatsy J. Trisler, J.D.

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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