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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number K920902
Device Name MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA
Applicant
3M HEALTH CARE, SARNS
6200 JACKSON RD.
PO BOX 1247
ANN ARBOR,  MI  48106
Applicant Contact CATHY L SIMPSON
Correspondent
3M HEALTH CARE, SARNS
6200 JACKSON RD.
PO BOX 1247
ANN ARBOR,  MI  48106
Correspondent Contact CATHY L SIMPSON
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/26/1992
Decision Date 05/11/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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