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 K895393
Device Name SARNS INGANT MEMBRANE OXYGENATOR
Applicant
3M Company
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Applicant Contact DENISE D SHIMOKCHI
Correspondent
3M Company
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Correspondent Contact DENISE D SHIMOKCHI
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received09/05/1989
Decision Date 12/04/1989
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
-
-