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FDA 510(k), K042132, NOVASYS TRANSURETHRAL RF SYSTEM
FDA 510(k), K042132, NOVASYS TRANSURETHRAL RF SYSTEM
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510(K) Number: K042132
Device Name: NOVASYS TRANSURETHRAL RF SYSTEM
Manufacturer: NOVASYS MEDICAL, INC.
Device Classification Name: applicator, transurethral, radio frequency, for stress urinary incontinence in women
Regulation Number: 878.4400
Classification Product Code: NVJ
Date Received: 08/09/2004
Decision Date: 12/21/2004
Regulation Medical Specialty: General & Plastic Surgery
Device Name: NOVASYS TRANSURETHRAL RF SYSTEM
Manufacturer: NOVASYS MEDICAL, INC.
Device Classification Name: applicator, transurethral, radio frequency, for stress urinary incontinence in women
Regulation Number: 878.4400
Classification Product Code: NVJ
Date Received: 08/09/2004
Decision Date: 12/21/2004
Regulation Medical Specialty: General & Plastic Surgery
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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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