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FDA 510(k)

HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H

K-Number: K871236 · 1987-05-29

ApplicantNational Medical Care, Medical Products Div., Inc.
Decision Date1987-05-29
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H is the device name listed in this FDA 510(k) record. The listed applicant is National Medical Care, Medical Products Div., Inc.. It received FDA 510(k) clearance on 1987-05-29 under 510(k) number K871236. 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 HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H?

HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H is a medical device that received FDA 510(k) clearance on 1987-05-29. The listed applicant is National Medical Care, Medical Products Div., Inc.. The 510(k) number is K871236.

When did HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H receive FDA 510(k) clearance?

HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H received FDA 510(k) clearance on 1987-05-29, under 510(k) number K871236.

Who is the listed applicant for HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H?

The FDA 510(k) record lists National Medical Care, Medical Products Div., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H?

The FDA product code for HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H is FJI.

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Other records listing National Medical Care, Medical Products Div., Inc. as applicant

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Related Devices (Code: FJI)

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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