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 K013164
Device Name SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
Applicant
TERUMO MEDICAL CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact BARBARA SMITH
Correspondent
TERUMO MEDICAL CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact BARBARA SMITH
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/21/2001
Decision Date 10/15/2001
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
-
-