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FDA 510(k)

DIALYZER, COIL, CD, LSA, 5M1765

K-Number: K770735 · 1977-05-10

ApplicantTravenol Laboratories, S.A.
Decision Date1977-05-10
Product CodeFHS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYZER, COIL, CD, LSA, 5M1765 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 1977-05-10 under 510(k) number K770735. The device is classified under product code FHS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALYZER, COIL, CD, LSA, 5M1765?

DIALYZER, COIL, CD, LSA, 5M1765 is a medical device that received FDA 510(k) clearance on 1977-05-10. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K770735.

When did DIALYZER, COIL, CD, LSA, 5M1765 receive FDA 510(k) clearance?

DIALYZER, COIL, CD, LSA, 5M1765 received FDA 510(k) clearance on 1977-05-10, under 510(k) number K770735.

Who is the listed applicant for DIALYZER, COIL, CD, LSA, 5M1765?

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 DIALYZER, COIL, CD, LSA, 5M1765?

The FDA product code for DIALYZER, COIL, CD, LSA, 5M1765 is FHS.

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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: FHS)

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.

K812811MICROCOIL 80 DIALYZERErika, Inc.K811974MICROCOIL 150 DIALYZERErika, Inc.K801634THE VITA 2 DISPOSABLE DIALYZERBellco Artifidial Organ Spec., Inc.K800723MICRO-COIL 100 COIL DIALYZERErika, Inc.K800174GAMBRO LUNDIA COIL DIALYZERGambro, Inc.K790223DIALYZER, CD-800 COILTravenol Laboratories, S.A.

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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