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 K010886
Device Name SIMPLICITY WING INFUSION SET
Applicant
STERLING MEDIVATIONS, INC.
180 FERNDALE RD. SOUTH
WAYZATA,  MN  55391
Applicant Contact JOEL S DOUGLASS
Correspondent
STERLING MEDIVATIONS, INC.
180 FERNDALE RD. SOUTH
WAYZATA,  MN  55391
Correspondent Contact JOEL S DOUGLASS
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/23/2001
Decision Date 04/30/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-