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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 K830057
Device Name 20 MICRON HIGH CAPACITY TRANS/FILTER
Applicant
Travenol Laboratories, S.A.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Travenol Laboratories, S.A.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5440
Classification Product Code
CAK  
Date Received01/07/1983
Decision Date 01/26/1983
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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