Device Classification Name |
Stimulator, Electrical, Non-Implantable, For Incontinence
More FDA Info for this Device |
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
Other 510(k) Applications for this Company
|
Contact |
Chiping Ma
Other 510(k) Applications for this Contact |
Regulation Number |
876.5320
More FDA Info for this Regulation Number |
Classification Product Code |
KPI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
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 |
|