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Hemodialysis Concentrates

by Dove Medical Supplies 510(k)

Active United States

510(k) K883068

Overview

Hemodialysis concentrates are liquid or powder solutions used in dialysis machines. They function to help remove waste products and excess electrolytes from the blood during the hemodialysis process.

This device is classified as a Class 2 medical device under regulation number 876.5820. It received FDA 510(k) clearance on December 22, 1988, under reference number K883068.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883068 Date22 Dec 1988ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KPO
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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