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 System And Accessories, Isolated Heart, Transport And Preservation
510(k) Number K032794
Device Name CUSTODIOL
Applicant
Dr. Franz Kohler Chemie GmbH
2305 Gold Mine Rd.
Brookeville,  MD  20833
Applicant Contact T. WHIT ATHEY
Correspondent
Dr. Franz Kohler Chemie GmbH
2305 Gold Mine Rd.
Brookeville,  MD  20833
Correspondent Contact T. WHIT ATHEY
Regulation Number876.5880
Classification Product Code
MSB  
Date Received09/08/2003
Decision Date 04/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-