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 K053177
Device Name MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
Applicant
MEDTRONIC MINIMED
18000 DEVONSHIRE STREET
NORTHRIDGE,  CA  91325
Applicant Contact STACI ELLIS
Correspondent
MEDTRONIC MINIMED
18000 DEVONSHIRE STREET
NORTHRIDGE,  CA  91325
Correspondent Contact STACI ELLIS
Regulation Number880.5725
Classification Product Code
LZG  
Date Received11/14/2005
Decision Date 01/31/2006
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
Recalls CDRH Recalls
-
-