FINESSE PERSONAL INSULIN DELIVERY PATCH

Pump, Infusion, Insulin Bolus

CALIBRA MEDICAL, INC.

The following data is part of a premarket notification filed by Calibra Medical, Inc. with the FDA for Finesse Personal Insulin Delivery Patch.

Pre-market Notification Details

Device IDK111924
510k NumberK111924
Device Name:FINESSE PERSONAL INSULIN DELIVERY PATCH
ClassificationPump, Infusion, Insulin Bolus
Applicant CALIBRA MEDICAL, INC. 220 SAGINAW DRIVE Redwood City,  CA  94063
ContactRichard J Meader
CorrespondentRichard J Meader
CALIBRA MEDICAL, INC. 220 SAGINAW DRIVE Redwood City,  CA  94063
Product CodeOPP  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-06
Decision Date2012-04-10
Summary:summary

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