FDA 510(k) Application Details - K093600

Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence

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510(K) Number K093600
Device Name Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant ACCELERATED CARE PLUS
4850 JOULE ST, STE A-1
RENO, NV 89502 US
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Contact PATRICK PARKER
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Regulation Number 876.5320

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Classification Product Code KPI
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Date Received 11/20/2009
Decision Date 12/04/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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