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FDA 510(k)

STERILE, DISPOSABLE CENTRIFUGE BOWL

K-Number: K791106 · 1979-08-10

ApplicantTravenol Laboratories, S.A.
Decision Date1979-08-10
Product CodeGKT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STERILE, DISPOSABLE CENTRIFUGE BOWL 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 1979-08-10 under 510(k) number K791106. The device is classified under product code GKT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE, DISPOSABLE CENTRIFUGE BOWL?

STERILE, DISPOSABLE CENTRIFUGE BOWL is a medical device that received FDA 510(k) clearance on 1979-08-10. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K791106.

When did STERILE, DISPOSABLE CENTRIFUGE BOWL receive FDA 510(k) clearance?

STERILE, DISPOSABLE CENTRIFUGE BOWL received FDA 510(k) clearance on 1979-08-10, under 510(k) number K791106.

Who is the listed applicant for STERILE, DISPOSABLE CENTRIFUGE BOWL?

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 STERILE, DISPOSABLE CENTRIFUGE BOWL?

The FDA product code for STERILE, DISPOSABLE CENTRIFUGE BOWL is GKT.

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

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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: GKT)

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.

K200530AMICUS Separator SystemFresenius Kabi AGK162462AMICUS Separator System, AMICUS Separator System; RefurbishedFresenius Kabi USA,LlcK822521AUTOMATED BLOOD CELL SEPARATORCryosan, Inc.K820396AUTOMATED BLOOD CELL SEPAR. DISP. SFTWRPheragen Technology Corp.K801233CELLTRIFUGE IITravenol Laboratories, S.A.K790105TERUMO IMUGARDTerumo America, 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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