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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K882720
Device Name SCIMED R30 SILICONE ASSIST RESERVOIR
Applicant
SCIMED LIFE SYSTEMS, INC.
13000 COUNTY RD 6
MINNEAPOLIS,  MN  55441
Applicant Contact SWANSON LANO
Correspondent
SCIMED LIFE SYSTEMS, INC.
13000 COUNTY RD 6
MINNEAPOLIS,  MN  55441
Correspondent Contact SWANSON LANO
Regulation Number870.4400
Classification Product Code
DTN  
Date Received07/01/1988
Decision Date 09/16/1988
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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