COSTORSOL— 510(k) K083453

Substantially Equivalent

Preservation Solutions, Inc.

FDA 510(k) clearance K083453 for COSTORSOL, Substantially Equivalent on 2009-01-21. Applicant: Preservation Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Preservation Solutions, Inc.
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2008-11-21
Decision date: 2009-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.