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FDA 510(k)

NIKKISO PARALLEL FLOW DIALYZERS

K-Number: K801065 · 1980-08-07

ApplicantInt'L Marketing & Sales Corp.
Decision Date1980-08-07
Product CodeFTG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIKKISO PARALLEL FLOW DIALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Int'L Marketing & Sales Corp.. It received FDA 510(k) clearance on 1980-08-07 under 510(k) number K801065. The device is classified under product code FTG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIKKISO PARALLEL FLOW DIALYZERS?

NIKKISO PARALLEL FLOW DIALYZERS is a medical device that received FDA 510(k) clearance on 1980-08-07. The listed applicant is Int'L Marketing & Sales Corp.. The 510(k) number is K801065.

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

NIKKISO PARALLEL FLOW DIALYZERS received FDA 510(k) clearance on 1980-08-07, under 510(k) number K801065.

Who is the listed applicant for NIKKISO PARALLEL FLOW DIALYZERS?

The FDA 510(k) record lists Int'L Marketing & Sales Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIKKISO PARALLEL FLOW DIALYZERS?

The FDA product code for NIKKISO PARALLEL FLOW DIALYZERS is FTG.

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Related Devices (Code: FTG)

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.

K760815FITTING/DIALYZERCobe Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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