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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K905673
Device Name AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183
Applicant
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT,  TX  77704
Applicant Contact PAT FRANKS
Correspondent
HELENA LABORATORIES
1530 LINDBERGH DR.
P.O. BOX 752
BEAUMONT,  TX  77704
Correspondent Contact PAT FRANKS
Regulation Number864.5425
Classification Product Code
GGN  
Date Received12/18/1990
Decision Date 02/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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