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 K925076
Device Name SARNS TURBO MEMBRANE OXYGENA. W/INT. CARDIOTOMY R.
Applicant
3M Health Care, Sarns
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Applicant Contact DENISE D SHIMOKOCHI
Correspondent
3M Health Care, Sarns
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Correspondent Contact DENISE D SHIMOKOCHI
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received10/07/1992
Decision Date 06/07/1993
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
-
-