• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name microfilter, blood transfusion
510(k) Number K830014
Device Name HEMA - NV TRANS. BLOOD FILTER 100/800
Original Applicant
ABBOTT LABORATORIES
one abbott park rd.
abbott park,  IL  60064 3500
Regulation Number880.5440
Classification Product Code
CAK  
Date Received01/03/1983
Decision Date 01/17/1983
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-