DRS 4 ND DIALYZER REPROCESSING SYSTEM— 510(k) K944539

Name: FDA 510(k) clearance K944539
Creator: U.S. Food and Drug Administration
Published: 1995-11-29

Substantially Equivalent

Seratronics, Inc.

FDA 510(k) clearance K944539 for DRS 4 ND DIALYZER REPROCESSING SYSTEM, Substantially Equivalent on 1995-11-29. Applicant: Seratronics, Inc.. Device class: 2.

Clearance details

Applicant: Seratronics, Inc.
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1994-09-15
Decision date: 1995-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

Download summary PDF View on FDA.gov ↗

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