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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 K834134
Device Name SARNS 8.0 SOFT ARC CANNULA
Applicant
3M HEALTH CARE, SARNS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
3M HEALTH CARE, SARNS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/30/1983
Decision Date 04/17/1984
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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