FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000— 510(k) K093065

Name: FDA 510(k) clearance K093065
Creator: U.S. Food and Drug Administration
Published: 2010-01-20

Substantially Equivalent

Calibra Medical, Inc.

FDA 510(k) clearance K093065 for FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000, Substantially Equivalent on 2010-01-20. Applicant: Calibra Medical, Inc.. Device class: 2.

Clearance details

Applicant: Calibra Medical, Inc.
Product code: Code OPP
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2009-09-30
Decision date: 2010-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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