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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K940082
Device Name THROMBOSCREEN THROMBOPLASTIN-DS
Applicant
PACIFIC HEMOSTASIS
11515 VANSTORY DR.
STE. 125
HUNTERSVILLE,  NC  28078
Applicant Contact JAMES MAYNARD, PH.D
Correspondent
PACIFIC HEMOSTASIS
11515 VANSTORY DR.
STE. 125
HUNTERSVILLE,  NC  28078
Correspondent Contact JAMES MAYNARD, PH.D
Regulation Number864.7750
Classification Product Code
GJS  
Date Received01/07/1994
Decision Date 02/14/1995
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
Recalls CDRH Recalls
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