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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K033137
Device Name POTENS +
Applicant
Wada, Inc.
35949 Nicolet Ct.
Fremont,  CA  94536
Applicant Contact GAIL RODRICK-HIGHBERG
Correspondent
Wada, Inc.
35949 Nicolet Ct.
Fremont,  CA  94536
Correspondent Contact GAIL RODRICK-HIGHBERG
Regulation Number864.5425
Classification Product Code
JPA  
Date Received09/30/2003
Decision Date 12/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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