WAVES— 510(k) K111521

Substantially Equivalent

Waters Medical Systems, LLC

FDA 510(k) clearance K111521 for WAVES, Substantially Equivalent on 2012-02-16. Applicant: Waters Medical Systems, LLC.

Clearance details

Applicant: Waters Medical Systems, LLC
Product code: Code KDN
Advisory panel: Gastroenterology, Urology
Date received: 2011-06-01
Decision date: 2012-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MN, US

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