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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 K971428
Device Name COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
Applicant
PACIFIC HEMOSTASIS
11515 VANSTORY DR.
HUNTERSVILLE,  NC  28078 -8144
Applicant Contact LAURA A WORFOLK
Correspondent
PACIFIC HEMOSTASIS
11515 VANSTORY DR.
HUNTERSVILLE,  NC  28078 -8144
Correspondent Contact LAURA A WORFOLK
Regulation Number864.5425
Classification Product Code
GGN  
Date Received04/17/1997
Decision Date 06/17/1997
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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