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
510(k) Number K131294
Device Name OMNIPOD INSULIN MANAGEMENT SYSTEM
Applicant
Insulet Corporation
9 Oak Park Dr.
Bedford,  MA  01730
Applicant Contact TARA N TURNEY
Correspondent
Insulet Corporation
9 Oak Park Dr.
Bedford,  MA  01730
Correspondent Contact TARA N TURNEY
Regulation Number880.5725
Classification Product Code
LZG  
Date Received05/06/2013
Decision Date 08/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-