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FDA 510(k)

EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS

K-Number: K802880 · 1980-12-17

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1980-12-17
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1980-12-17 under 510(k) number K802880. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS?

EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS is a medical device that received FDA 510(k) clearance on 1980-12-17. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K802880.

When did EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS receive FDA 510(k) clearance?

EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS received FDA 510(k) clearance on 1980-12-17, under 510(k) number K802880.

Who is the listed applicant for EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS?

The FDA 510(k) record lists Extracorporeal Medical Specialities, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS?

The FDA product code for EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS is FKP.

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Other records listing Extracorporeal Medical Specialities, 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.

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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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