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FDA 510(k)

NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER

K-Number: K904566 · 1990-12-12

ApplicantCobe Laboratories, Inc.
Decision Date1990-12-12
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1990-12-12 under 510(k) number K904566. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER?

NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER is a medical device that received FDA 510(k) clearance on 1990-12-12. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K904566.

When did NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER receive FDA 510(k) clearance?

NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER received FDA 510(k) clearance on 1990-12-12, under 510(k) number K904566.

Who is the listed applicant for NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER?

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

What is the FDA product code for NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER?

The FDA product code for NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER is FJI.

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Other records listing Cobe Laboratories, 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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

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Related Devices (Code: FJI)

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.

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLCK122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical CorporationK043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal ProductsK010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

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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