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 Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K851613
Device Name CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER
Applicant
Centrimed Corp.
651 Sixteenth Ave. S.
Hopkins,  MN  55343
Applicant Contact LLOYD HUBBARD
Correspondent
Centrimed Corp.
651 Sixteenth Ave. S.
Hopkins,  MN  55343
Correspondent Contact LLOYD HUBBARD
Regulation Number870.4360
Classification Product Code
KFM  
Date Received04/19/1985
Decision Date 06/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-