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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K984131
Device Name COAGULATION CONTROL LEVEL 3 (ABNORMAL)
Applicant
Pacific Hemostasis
11515 Vanstory Dr.
Huntersville,  NC  28078
Applicant Contact MARK ELLIS
Correspondent
Pacific Hemostasis
11515 Vanstory Dr.
Huntersville,  NC  28078
Correspondent Contact MARK ELLIS
Regulation Number864.5425
Classification Product Code
GGC  
Date Received11/18/1998
Decision Date 12/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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