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 Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K896020
Device Name EXTRACORPOREAL HEAT EXCHANGER HE SERIES
Applicant
Gish Biomedical, Inc.
2350 S. Pullman Ave.
Santa Ana,  CA  92705
Applicant Contact MARY DEARMOND
Correspondent
Gish Biomedical, Inc.
2350 S. Pullman Ave.
Santa Ana,  CA  92705
Correspondent Contact MARY DEARMOND
Regulation Number870.4240
Classification Product Code
DTR  
Date Received10/16/1989
Decision Date 05/17/1990
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
-
-