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 Set, Administration, Intravascular
510(k) Number K021005
Device Name SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE
Applicant
STERLING MEDIVATIONS, INC.
25285 LA LOMA DR.
LOS ALTOS HILLS,  CA  94022 -4583
Applicant Contact JOEL DOUGLAS
Correspondent
STERLING MEDIVATIONS, INC.
25285 LA LOMA DR.
LOS ALTOS HILLS,  CA  94022 -4583
Correspondent Contact JOEL DOUGLAS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/28/2002
Decision Date 04/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-