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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pad, heating, powered
510(k) Number K133981
Device Name AVACEN 100
Applicant
AVACEN INC.
7920 SILVERTON AVENUE
SUITE L
san diego,  CA  92126
Applicant Contact thomas g muehlabuer
Correspondent
AVACEN INC.
7920 SILVERTON AVENUE
SUITE L
san diego,  CA  92126
Correspondent Contact thomas g muehlabuer
Regulation Number890.5740
Classification Product Code
IRT  
Date Received12/26/2013
Decision Date 08/15/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
summary summary
Type Abbreviated
Clinical Trials NCT01619579
Reviewed by Third Party No
Combination Product No
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