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FDA 510(k)

DIALYZER, CAPILLARY, HOLLOW FIBER

K-Number: K853591 · 1985-09-11

ApplicantOrganon Teknika Corp.
Decision Date1985-09-11
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYZER, CAPILLARY, HOLLOW FIBER 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 1985-09-11 under 510(k) number K853591. 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 DIALYZER, CAPILLARY, HOLLOW FIBER?

DIALYZER, CAPILLARY, HOLLOW FIBER is a medical device that received FDA 510(k) clearance on 1985-09-11. The listed applicant is Organon Teknika Corp.. The 510(k) number is K853591.

When did DIALYZER, CAPILLARY, HOLLOW FIBER receive FDA 510(k) clearance?

DIALYZER, CAPILLARY, HOLLOW FIBER received FDA 510(k) clearance on 1985-09-11, under 510(k) number K853591.

Who is the listed applicant for DIALYZER, CAPILLARY, HOLLOW FIBER?

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 DIALYZER, CAPILLARY, HOLLOW FIBER?

The FDA product code for DIALYZER, CAPILLARY, HOLLOW FIBER is FJI.

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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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