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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 K992829
Device Name CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
Applicant
Medical Analysis Systems, Inc.
542 Flynn Rd.
Camarillo,  CA  93012 -8058
Applicant Contact MARY D THORSNESS
Correspondent
Medical Analysis Systems, Inc.
542 Flynn Rd.
Camarillo,  CA  93012 -8058
Correspondent Contact MARY D THORSNESS
Regulation Number864.5425
Classification Product Code
GGN  
Date Received08/23/1999
Decision Date 11/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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