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FDA 510(k)

PRE-FILLED SYRINGE & CYSTOFLO URINARY BG

K-Number: K811924 · 1981-11-10

ApplicantTravenol Laboratories, S.A.
Decision Date1981-11-10
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRE-FILLED SYRINGE & CYSTOFLO URINARY BG is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1981-11-10 under 510(k) number K811924. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-FILLED SYRINGE & CYSTOFLO URINARY BG?

PRE-FILLED SYRINGE & CYSTOFLO URINARY BG is a medical device that received FDA 510(k) clearance on 1981-11-10. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K811924.

When did PRE-FILLED SYRINGE & CYSTOFLO URINARY BG receive FDA 510(k) clearance?

PRE-FILLED SYRINGE & CYSTOFLO URINARY BG received FDA 510(k) clearance on 1981-11-10, under 510(k) number K811924.

Who is the listed applicant for PRE-FILLED SYRINGE & CYSTOFLO URINARY BG?

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

What is the FDA product code for PRE-FILLED SYRINGE & CYSTOFLO URINARY BG?

The FDA product code for PRE-FILLED SYRINGE & CYSTOFLO URINARY BG is KOD.

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Other records listing Travenol Laboratories, S.A. as applicant

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Related Devices (Code: KOD)

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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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