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FDA 510(k)

GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER

K-Number: K883589 · 1988-09-29

ApplicantGambro, Inc.
Decision Date1988-09-29
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1988-09-29 under 510(k) number K883589. 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 GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER?

GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER is a medical device that received FDA 510(k) clearance on 1988-09-29. The listed applicant is Gambro, Inc.. The 510(k) number is K883589.

When did GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER receive FDA 510(k) clearance?

GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER received FDA 510(k) clearance on 1988-09-29, under 510(k) number K883589.

Who is the listed applicant for GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER?

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

What is the FDA product code for GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER?

The FDA product code for GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER is FJI.

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Other records listing Gambro, 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.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

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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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