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FDA 510(k)

ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7

K-Number: K861536 · 1986-07-10

ApplicantNational Medical Care, Medical Products Div., Inc.
Decision Date1986-07-10
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7 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 1986-07-10 under 510(k) number K861536. 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 ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7?

ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7 is a medical device that received FDA 510(k) clearance on 1986-07-10. The listed applicant is National Medical Care, Medical Products Div., Inc.. The 510(k) number is K861536.

When did ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7 receive FDA 510(k) clearance?

ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7 received FDA 510(k) clearance on 1986-07-10, under 510(k) number K861536.

Who is the listed applicant for ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7?

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 ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7?

The FDA product code for ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7 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)

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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