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 K210714
Device Name Extended Reservoir
Applicant
Medtronic Minimed, Inc.
18000 Devonshire St.
Northridge,  CA  91325
Applicant Contact Prerna Singh
Correspondent
Medtronic Minimed, Inc.
18000 Devonshire St.
Northridge,  CA  91325
Correspondent Contact Christina Rowe
Regulation Number880.5725
Classification Product Code
LZG  
Date Received03/10/2021
Decision Date 04/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-