• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name set, administration, intravascular
510(k) Number K980583
Device Name EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE
Original Applicant
SIMS DELTEC, INC.
1265 grey fox rd.
st. paul,  MN  55112
Original Contact david h short
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/17/1998
Decision Date 04/27/1998
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
-
-