FINESSE PERSONAL INSULIN DELIVERY PATCH


Device Classification Name

pump, infusion, insulin bolus

510(k) Number K111924
Device Name FINESSE PERSONAL INSULIN DELIVERY PATCH
Applicant
CALIBRA MEDICAL, INC.
220 saginaw drive
redwood city, 
CA 
94063

Applicant Contact richard j meader
Correspondent
CALIBRA MEDICAL, INC.
220 saginaw drive
redwood city, 
CA 
94063

Correspodent Contact richard j meader
Regulation Number 880.5725
Classification Product Code
OPP  
Subsequent Product Code
LZG  
Date Received 07/06/2011
Decision Date 04/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Clinical Trials NCT01073566
Reviewed by Third Party No

Combination Product

No