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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microfilter, Blood Transfusion
510(k) Number K855064
Device Name SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE
Applicant
Cobe Laboratories, Inc.
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact VERA BUFFALOE
Correspondent
Cobe Laboratories, Inc.
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact VERA BUFFALOE
Regulation Number880.5440
Classification Product Code
CAK  
Date Received12/18/1985
Decision Date 03/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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