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FDA 510(k), K990041, UROSTYM BIOFEEDBACK AND STIMULATION PROBES
FDA 510(k), K990041, UROSTYM BIOFEEDBACK AND STIMULATION PROBES
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510(K) Number: K990041
Device Name: UROSTYM BIOFEEDBACK AND STIMULATION PROBES
Manufacturer: LABORIE MEDICAL TECH CORP.
Device Classification Name: stimulator, electrical, non-implantable, for incontinence
Regulation Number: 876.5320
Classification Product Code: KPI
Date Received: 01/06/1999
Decision Date: 08/05/1999
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: UROSTYM BIOFEEDBACK AND STIMULATION PROBES
Manufacturer: LABORIE MEDICAL TECH CORP.
Device Classification Name: stimulator, electrical, non-implantable, for incontinence
Regulation Number: 876.5320
Classification Product Code: KPI
Date Received: 01/06/1999
Decision Date: 08/05/1999
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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