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FDA 510(k)

DPS 4 DIALYZER PREPARATION SYSTEM

K-Number: K955299 · 1996-10-21

ApplicantSeratronics, Inc.
Decision Date1996-10-21
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DPS 4 DIALYZER PREPARATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Seratronics, Inc.. It received FDA 510(k) clearance on 1996-10-21 under 510(k) number K955299. The device is classified under product code LIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DPS 4 DIALYZER PREPARATION SYSTEM?

DPS 4 DIALYZER PREPARATION SYSTEM is a medical device that received FDA 510(k) clearance on 1996-10-21. The listed applicant is Seratronics, Inc.. The 510(k) number is K955299.

When did DPS 4 DIALYZER PREPARATION SYSTEM receive FDA 510(k) clearance?

DPS 4 DIALYZER PREPARATION SYSTEM received FDA 510(k) clearance on 1996-10-21, under 510(k) number K955299.

Who is the listed applicant for DPS 4 DIALYZER PREPARATION SYSTEM?

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

What is the FDA product code for DPS 4 DIALYZER PREPARATION SYSTEM?

The FDA product code for DPS 4 DIALYZER PREPARATION SYSTEM is LIF.

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Other records listing Seratronics, 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.

K931336DRS 4 DIALYZER REPROCESSING SYSTEMK944539DRS 4 ND DIALYZER REPROCESSING SYSTEMK923529DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCESK914580DRS-4 DIALYZER REPROCESSING SYSTEMK874573FRESENIUS PURISTERIL 340 (TM)K874872FRESENIUS HEMOFLOW F3, F4, F5, F7

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Related Devices (Code: LIF)

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.

K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux TechnologiesK043126ASSIST HEADER CLEANERAlcavis International, Inc.K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International Incorporated

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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