RM3 RENAL PRESERVATION SYSTEM— 510(k) K042224

Name: FDA 510(k) clearance K042224
Creator: U.S. Food and Drug Administration
Published: 2004-10-22

Substantially Equivalent

Waters Instruments, Inc.

FDA 510(k) clearance K042224 for RM3 RENAL PRESERVATION SYSTEM, Substantially Equivalent on 2004-10-22. 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: 2004-08-17
Decision date: 2004-10-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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