Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name pump, infusion, insulin bolus
510(k) Number K100947
Device Name FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
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
Correspondent Contact RICHARD J MEADER
Regulation Number880.5725
Classification Product Code
OPP  
Date Received04/06/2010
Decision Date 06/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-