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FDA 510(k)

GAMBRO LUNDIA PRO 3 & 5 DIALYZER

K-Number: K853406 · 1986-01-08

ApplicantGambro, Inc.
Decision Date1986-01-08
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO LUNDIA PRO 3 & 5 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 1986-01-08 under 510(k) number K853406. The device is classified under product code FJG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO LUNDIA PRO 3 & 5 DIALYZER?

GAMBRO LUNDIA PRO 3 & 5 DIALYZER is a medical device that received FDA 510(k) clearance on 1986-01-08. The listed applicant is Gambro, Inc.. The 510(k) number is K853406.

When did GAMBRO LUNDIA PRO 3 & 5 DIALYZER receive FDA 510(k) clearance?

GAMBRO LUNDIA PRO 3 & 5 DIALYZER received FDA 510(k) clearance on 1986-01-08, under 510(k) number K853406.

Who is the listed applicant for GAMBRO LUNDIA PRO 3 & 5 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 LUNDIA PRO 3 & 5 DIALYZER?

The FDA product code for GAMBRO LUNDIA PRO 3 & 5 DIALYZER is FJG.

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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: FJG)

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.

K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.K933680GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.K920693DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9National Medical Care, Medical Products Div., Inc.K915504GAMBRO LUNDIA ALPHA HEMODIALYZERSC.G.H. Medical, Inc.K901368HEMOSPAL KITS A1, A2D, AO, & A1DGambro-Hospal, Inc.K902203TENCKHOFF PERITONEAL DIALYSIS KITAkcess Medical Products, Inc.

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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