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FDA 510(k)

PARALLEL PLATE DIALYZERS

K-Number: K771354 · 1977-09-15

ApplicantHospal Medical Corp.
Decision Date1977-09-15
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PARALLEL PLATE DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Hospal Medical Corp.. It received FDA 510(k) clearance on 1977-09-15 under 510(k) number K771354. 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 PARALLEL PLATE DIALYZERS?

PARALLEL PLATE DIALYZERS is a medical device that received FDA 510(k) clearance on 1977-09-15. The listed applicant is Hospal Medical Corp.. The 510(k) number is K771354.

When did PARALLEL PLATE DIALYZERS receive FDA 510(k) clearance?

PARALLEL PLATE DIALYZERS received FDA 510(k) clearance on 1977-09-15, under 510(k) number K771354.

Who is the listed applicant for PARALLEL PLATE DIALYZERS?

The FDA 510(k) record lists Hospal Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARALLEL PLATE DIALYZERS?

The FDA product code for PARALLEL PLATE DIALYZERS is FJG.

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Other records listing Hospal Medical Corp. 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.

K893742FILTRAL TM 20 HEMODIALYZER/FILTERK884365MULTIFLOW(TM) 60 KITK884326FILTRAL TM 8 HEMODIALYZERK883307CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KITK872767FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZERK871218MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT

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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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