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FDA 510(k)

DOUBLE ELUTRA-PACK UNIT

K-Number: K760914 · 1976-11-23

ApplicantTravenol Laboratories, S.A.
Decision Date1976-11-23
Product CodeKSW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DOUBLE ELUTRA-PACK UNIT 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 1976-11-23 under 510(k) number K760914. The device is classified under product code KSW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOUBLE ELUTRA-PACK UNIT?

DOUBLE ELUTRA-PACK UNIT is a medical device that received FDA 510(k) clearance on 1976-11-23. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K760914.

When did DOUBLE ELUTRA-PACK UNIT receive FDA 510(k) clearance?

DOUBLE ELUTRA-PACK UNIT received FDA 510(k) clearance on 1976-11-23, under 510(k) number K760914.

Who is the listed applicant for DOUBLE ELUTRA-PACK UNIT?

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 DOUBLE ELUTRA-PACK UNIT?

The FDA product code for DOUBLE ELUTRA-PACK UNIT is KSW.

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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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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