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 K003145
Device Name ORIGEN BLADDER HOLDER
Applicant
ORIGEN BIOMEDICAL, INC.
2525 HARTFORD RD.
AUSTIN,  TX  78703 -2428
Applicant Contact RICHARD MARTIN
Correspondent
ORIGEN BIOMEDICAL, INC.
2525 HARTFORD RD.
AUSTIN,  TX  78703 -2428
Correspondent Contact RICHARD MARTIN
Regulation Number870.4250
Classification Product Code
DWC  
Date Received10/10/2000
Decision Date 04/20/2001
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
-
-