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 Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K093992
Device Name TERUMO LAUER LOCK ADAPTER
Applicant
Terumo Cardiovascular Systems Corporation
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact EILEEN DORSEY
Correspondent
Terumo Cardiovascular Systems Corporation
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact EILEEN DORSEY
Regulation Number870.4290
Classification Product Code
DTL  
Date Received12/24/2009
Decision Date 05/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-