RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT— 510(k) K971571

Name: FDA 510(k) clearance K971571
Creator: U.S. Food and Drug Administration
Published: 1997-07-29

Substantially Equivalent

Waters Instruments, Inc.

FDA 510(k) clearance K971571 for RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT, Substantially Equivalent on 1997-07-29. Applicant: Waters Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Waters Instruments, Inc.
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 1997-04-30
Decision date: 1997-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MN, US

Download summary PDF View on FDA.gov ↗

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