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FDA 510(k)

SORB SYSTEM URS

K-Number: K792137 · 1980-01-16

ApplicantOrganon Teknika Corp.
Decision Date1980-01-16
Product CodeFKT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SORB SYSTEM URS is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1980-01-16 under 510(k) number K792137. The device is classified under product code FKT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SORB SYSTEM URS?

SORB SYSTEM URS is a medical device that received FDA 510(k) clearance on 1980-01-16. The listed applicant is Organon Teknika Corp.. The 510(k) number is K792137.

When did SORB SYSTEM URS receive FDA 510(k) clearance?

SORB SYSTEM URS received FDA 510(k) clearance on 1980-01-16, under 510(k) number K792137.

Who is the listed applicant for SORB SYSTEM URS?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SORB SYSTEM URS?

The FDA product code for SORB SYSTEM URS is FKT.

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Other records listing Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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Related Devices (Code: FKT)

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.

K1238352008 HEMODIALYSIS SORBENT SYSTEMRenal Solutions, Inc.K0933622008 HEMODIALYSIS SORBENT SYSTEMRenal Solutions, Inc.K070739ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500Renal Solutions, Inc.K060381ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100Renal Solutions, Inc.K043574ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000Renal Solutions, Inc.K031099SORB+HISORB+CARTRIDGERenal Solutions, 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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