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 Syringe, Piston
510(k) Number K150874
Device Name NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
Applicant
Novo Nordisk, Inc.
P.O Box 846
Plainsboro,  NJ  08536
Applicant Contact Poonam Tuliani
Correspondent
Novo Nordisk, Inc.
P.O Box 846
Plainsboro,  NJ  08536
Correspondent Contact Poonam Tuliani
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/01/2015
Decision Date 07/31/2015
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-