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FDA 510(k)

LUNDIA PLATE DISPOSABLE DIALYZER

K-Number: K780700 · 1978-07-17

ApplicantGambro, Inc.
Decision Date1978-07-17
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LUNDIA PLATE DISPOSABLE 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 1978-07-17 under 510(k) number K780700. 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 LUNDIA PLATE DISPOSABLE DIALYZER?

LUNDIA PLATE DISPOSABLE DIALYZER is a medical device that received FDA 510(k) clearance on 1978-07-17. The listed applicant is Gambro, Inc.. The 510(k) number is K780700.

When did LUNDIA PLATE DISPOSABLE DIALYZER receive FDA 510(k) clearance?

LUNDIA PLATE DISPOSABLE DIALYZER received FDA 510(k) clearance on 1978-07-17, under 510(k) number K780700.

Who is the listed applicant for LUNDIA PLATE DISPOSABLE 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 LUNDIA PLATE DISPOSABLE DIALYZER?

The FDA product code for LUNDIA PLATE DISPOSABLE 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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