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FDA 510(k)

SOLUTION ADMIN. SETS W/FLASHBALL

K-Number: K831311 · 1983-06-08

ApplicantTravenol Laboratories, S.A.
Decision Date1983-06-08
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SOLUTION ADMIN. SETS W/FLASHBALL 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 1983-06-08 under 510(k) number K831311. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLUTION ADMIN. SETS W/FLASHBALL?

SOLUTION ADMIN. SETS W/FLASHBALL is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K831311.

When did SOLUTION ADMIN. SETS W/FLASHBALL receive FDA 510(k) clearance?

SOLUTION ADMIN. SETS W/FLASHBALL received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831311.

Who is the listed applicant for SOLUTION ADMIN. SETS W/FLASHBALL?

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 SOLUTION ADMIN. SETS W/FLASHBALL?

The FDA product code for SOLUTION ADMIN. SETS W/FLASHBALL is FPA.

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Other records listing Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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