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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suction Control, Intracardiac, Cardiopulmonary Bypass
510(k) Number K863593
Device Name SARNS SAFETY LOOP
Applicant
3M Health Care, Sarns
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Applicant Contact JOSEPH W O'DONNELL
Correspondent
3M Health Care, Sarns
6200 Jackson Rd.
P.O. Box 1247
Ann Arbor,  MI  48106
Correspondent Contact JOSEPH W O'DONNELL
Regulation Number870.4430
Classification Product Code
DWD  
Date Received09/15/1986
Decision Date 11/18/1986
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
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