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
510(k) Number K001829
Device Name MINIMED PARADIGM INSULIN PUMP, MODEL 511
Applicant
MINIMED, INC.
12744 SAN FERNANDO RD.
SYLMAR,  CA  91342
Applicant Contact JENNIFER LYONS
Correspondent
MINIMED, INC.
12744 SAN FERNANDO RD.
SYLMAR,  CA  91342
Correspondent Contact JENNIFER LYONS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/16/2000
Decision Date 08/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-