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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K093205
Device Name PADCHECK
Applicant
Padtest, LLC
801 S. Grand Ave.
#1907
Los Angeles,  CA  90017
Applicant Contact JAMES R GREENWOOD
Correspondent
Padtest, LLC
801 S. Grand Ave.
#1907
Los Angeles,  CA  90017
Correspondent Contact JAMES R GREENWOOD
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/13/2009
Decision Date 04/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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