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FDA 510(k)

LUBE JEL

K-Number: K771364 · 1977-08-02

ApplicantTravenol Laboratories, S.A.
Decision Date1977-08-02
Product CodeFHX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LUBE JEL 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 1977-08-02 under 510(k) number K771364. The device is classified under product code FHX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUBE JEL?

LUBE JEL is a medical device that received FDA 510(k) clearance on 1977-08-02. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K771364.

When did LUBE JEL receive FDA 510(k) clearance?

LUBE JEL received FDA 510(k) clearance on 1977-08-02, under 510(k) number K771364.

Who is the listed applicant for LUBE JEL?

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 LUBE JEL?

The FDA product code for LUBE JEL is FHX.

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: FHX)

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.

K081990LUBRICANO STERILE GELFarco Pharma GmbHK951713BUTTON LUBRICATORFibertech Instruments, Inc.K935548CATHEJELL S STERILE LUBRICATING JELLYPharmazeutische Fabrik Montavit GmbHK912132OPERAND LUBRICATING JELLYGeneral Medical Co.K780386K-Y LUBRICATING JELLYJohnson & Johnson Professionals, Inc.

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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