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 Microfilter, Blood Transfusion
510(k) Number K890844
Device Name MICROSEPT 60/20
Applicant
Arbor Technologies, Inc.
3728 Plz. Dr.
Ann Arbor,  MI  48108
Applicant Contact DAWN I MOORE
Correspondent
Arbor Technologies, Inc.
3728 Plz. Dr.
Ann Arbor,  MI  48108
Correspondent Contact DAWN I MOORE
Regulation Number880.5440
Classification Product Code
CAK  
Date Received02/21/1989
Decision Date 06/07/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-