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FDA 510(k), K101847, URGENT PC STIMULATOR; URGENT PC LEAD SET
FDA 510(k), K101847, URGENT PC STIMULATOR; URGENT PC LEAD SET
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$149.00 USD
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510(K) Number: K101847
Device Name: URGENT PC STIMULATOR; URGENT PC LEAD SET
Manufacturer: UROPLASTY, INC.
Device Classification Name: stimulator, peripheral nerve, non-implanted, for urinary incontinence
Regulation Number: 876.5310
Classification Product Code: NAM
Date Received: 07/01/2010
Decision Date: 10/21/2010
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: URGENT PC STIMULATOR; URGENT PC LEAD SET
Manufacturer: UROPLASTY, INC.
Device Classification Name: stimulator, peripheral nerve, non-implanted, for urinary incontinence
Regulation Number: 876.5310
Classification Product Code: NAM
Date Received: 07/01/2010
Decision Date: 10/21/2010
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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