FDA 510(k) Application Details - K142369

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

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510(K) Number K142369
Device Name Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD
F19, NO. 1 KESHENG ROAD, BAIYUN TORCH, BUILDING, NO. 1633
BEITAI RAOD,BAIYUN
GUANGZHOU 510040 CN
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Contact Chiping Ma
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Regulation Number 876.5320

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Classification Product Code KPI
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Date Received 08/25/2014
Decision Date 06/17/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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