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 K853749
Device Name CUSTOM CORONARY MANIFOLD KITS
Applicant
Procedure Products, Inc.
1801 W. 4th Plain Blvd.
Vancouver,  WA  98660
Applicant Contact KURT GEORGE
Correspondent
Procedure Products, Inc.
1801 W. 4th Plain Blvd.
Vancouver,  WA  98660
Correspondent Contact KURT GEORGE
Regulation Number870.4290
Classification Product Code
DTL  
Date Received09/09/1985
Decision Date 01/13/1986
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
-
-