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 K883956
Device Name BIO-MEDICUS TUBING CONNECTORS
Applicant
Bio Medicus, Inc.
9600 W. 76 St.
Eden Prairie,  MN  55344
Applicant Contact JOHN R DALPEE
Correspondent
Bio Medicus, Inc.
9600 W. 76 St.
Eden Prairie,  MN  55344
Correspondent Contact JOHN R DALPEE
Regulation Number870.4290
Classification Product Code
DTL  
Date Received09/19/1988
Decision Date 10/28/1988
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
-
-