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FDA 510(k), K081990, LUBRICANO STERILE GEL
FDA 510(k), K081990, LUBRICANO STERILE GEL
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510(K) Number: K081990
Device Name: LUBRICANO STERILE GEL
Manufacturer: FARCO PHARMA GMBH
Device Classification Name: jelly, lubricating, for transurethral surgical instrument
Regulation Number: 876.1500
Classification Product Code: FHX
Date Received: 07/14/2008
Decision Date: 12/05/2008
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: LUBRICANO STERILE GEL
Manufacturer: FARCO PHARMA GMBH
Device Classification Name: jelly, lubricating, for transurethral surgical instrument
Regulation Number: 876.1500
Classification Product Code: FHX
Date Received: 07/14/2008
Decision Date: 12/05/2008
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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