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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, electrical, non-implantable, for incontinence
510(k) Number K121820
Device Name INWAVE
Original Applicant
9990 park meadows dr.
lone tree,  CO  80124
Original Contact jim arnold
Regulation Number876.5320
Classification Product Code
Date Received06/21/2012
Decision Date 08/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
statement statement
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No