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 Controller, Temperature, Cardiopulmonary Bypass
510(k) Number K896974
Device Name CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120
Applicant
Daily Medical Products, Inc.
3665 Kearny Villa Rd.
Suite 301
San Diego,  CA  92123
Applicant Contact ALAN SECORD
Correspondent
Daily Medical Products, Inc.
3665 Kearny Villa Rd.
Suite 301
San Diego,  CA  92123
Correspondent Contact ALAN SECORD
Regulation Number870.4250
Classification Product Code
DWC  
Date Received12/13/1989
Decision Date 02/05/1990
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
-
-