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
Predetermined Change
Control Plan Authorized		 No
-
-