PERF-GEN PULSATILE PERFUSION SOLUTION— 510(k) K121736

Name: FDA 510(k) clearance K121736
Creator: U.S. Food and Drug Administration
Published: 2013-08-16

Substantially Equivalent

Waters Medical Systems, LLC

FDA 510(k) clearance K121736 for PERF-GEN PULSATILE PERFUSION SOLUTION, Substantially Equivalent on 2013-08-16. Applicant: Waters Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Waters Medical Systems, LLC
Product code: Code KDL
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2012-06-13
Decision date: 2013-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MN, US

Download summary PDF View on FDA.gov ↗

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