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 Analyzer, Heparin, Automated
510(k) Number K111339
Device Name HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
Applicant
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Applicant Contact AMRA RACIC
Correspondent
Medtronic, Inc.
8200 Coral Sea St. N.E
Mounds View,  MN  55112
Correspondent Contact AMRA RACIC
Regulation Number864.5680
Classification Product Code
JOX  
Date Received05/12/2011
Decision Date 06/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-