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 oxygenator, cardiopulmonary bypass
510(k) Number K842908
Device Name VARIABLE PRIME COBE MEMBRANE LUNG
Applicant
COBE LABORATORIES, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Applicant Contact HOLLAND HICKEY
Correspondent
COBE LABORATORIES, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Correspondent Contact HOLLAND HICKEY
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received07/24/1984
Decision Date 02/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-