SHERPA PAK TRANSPORTER— 510(k) K133694

Name: FDA 510(k) clearance K133694
Creator: U.S. Food and Drug Administration
Published: 2014-05-23

Substantially Equivalent

Paragonix Technologies, Inc.

FDA 510(k) clearance K133694 for SHERPA PAK TRANSPORTER, Substantially Equivalent on 2014-05-23. Applicant: Paragonix Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Paragonix Technologies, Inc.
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2013-12-03
Decision date: 2014-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, RI, 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.