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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation
510(k) Number K991321
Device Name PACIFIC HEMOSTASIS THROMBOSCREEN 200
Applicant
Pacific Hemostasis
11515 Vanstory Dr.
Huntersville,  NC  28078
Applicant Contact LARRY KOPYTA
Correspondent
Pacific Hemostasis
11515 Vanstory Dr.
Huntersville,  NC  28078
Correspondent Contact LARRY KOPYTA
Regulation Number864.5400
Classification Product Code
KQG  
Date Received04/19/1999
Decision Date 06/21/1999
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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