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FDA 510(k)

HEMODIALYZERS RP-510 AND RP-514

K-Number: K791448 · 1979-08-07

ApplicantHospal Medical Corp.
Decision Date1979-08-07
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMODIALYZERS RP-510 AND RP-514 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 1979-08-07 under 510(k) number K791448. 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 HEMODIALYZERS RP-510 AND RP-514?

HEMODIALYZERS RP-510 AND RP-514 is a medical device that received FDA 510(k) clearance on 1979-08-07. The listed applicant is Hospal Medical Corp.. The 510(k) number is K791448.

When did HEMODIALYZERS RP-510 AND RP-514 receive FDA 510(k) clearance?

HEMODIALYZERS RP-510 AND RP-514 received FDA 510(k) clearance on 1979-08-07, under 510(k) number K791448.

Who is the listed applicant for HEMODIALYZERS RP-510 AND RP-514?

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 HEMODIALYZERS RP-510 AND RP-514?

The FDA product code for HEMODIALYZERS RP-510 AND RP-514 is FJG.

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Other records listing Hospal Medical Corp. as applicant

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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.

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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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