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FDA 510(k), K162010, HPM-6000U
FDA 510(k), K162010, HPM-6000U
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510(K) Number: K162010
Device Name: HPM-6000U
Manufacturer: Jan Zarsky
Device Classification Name: Stimulator, Electrical, Non-Implantable, For Incontinence
Regulation Number: KPI
Classification Product Code: 07/20/2016
Date Received: 12/13/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: HPM-6000U
Manufacturer: Jan Zarsky
Device Classification Name: Stimulator, Electrical, Non-Implantable, For Incontinence
Regulation Number: KPI
Classification Product Code: 07/20/2016
Date Received: 12/13/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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