• 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 needle, hypodermic, single lumen
510(k) Number K160199
Device Name Advocate Insulin Pen Needles
Applicant
Diabetic Supply of Suncoast, Inc.
Bo.Espinosa Carr.2km.26.2
Dorado,  PR  00646 -9532
Applicant Contact Victoria Thuss
Correspondent
Matt Hedlund
3924 NE 157th PL
Lake Forest Park,  WA  98155
Correspondent Contact Matt Hedlund
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/28/2016
Decision Date 10/19/2016
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
-
-