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FDA 510(k)

PARALLEL PLATE DIALYZER HOLDER

K-Number: K811292 · 1981-06-02

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1981-06-02
Product CodeFKI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PARALLEL PLATE DIALYZER HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1981-06-02 under 510(k) number K811292. The device is classified under product code FKI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARALLEL PLATE DIALYZER HOLDER?

PARALLEL PLATE DIALYZER HOLDER is a medical device that received FDA 510(k) clearance on 1981-06-02. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K811292.

When did PARALLEL PLATE DIALYZER HOLDER receive FDA 510(k) clearance?

PARALLEL PLATE DIALYZER HOLDER received FDA 510(k) clearance on 1981-06-02, under 510(k) number K811292.

Who is the listed applicant for PARALLEL PLATE DIALYZER HOLDER?

The FDA 510(k) record lists Extracorporeal Medical Specialities, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARALLEL PLATE DIALYZER HOLDER?

The FDA product code for PARALLEL PLATE DIALYZER HOLDER is FKI.

Related Clinical Trials

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.

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Other records listing Extracorporeal Medical Specialities, Inc. 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840262HANCOCK PERICARDIAL PATCHK840532HEMOPERFUSION SYSTEM TP-400K840057EXP* 500 PARALLEL PLATE DIALYZERK840146EXP* 700 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLER

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Related Devices (Code: FKI)

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.

K843504AMER. BENTLEY HEMOFILTER HOLDER HFH-1American BentleyK802075HOLLOW FIBER DIALYZER HOLDERRenal Devices, 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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