510(k) K081990
K081990 is an FDA 510(k) premarket notification submitted by Farco Pharma GmbH for the device "LUBRICANO STERILE GEL". The FDA issued a decision of Substantially Equivalent on December 5, 2008. The device falls under product code FHX (Jelly, Lubricating, For Transurethral Surgical Instrument), a Class II device regulated under 21 CFR 876.1500. Farco Pharma GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2008
- Date Received
- July 14, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Jelly, Lubricating, For Transurethral Surgical Instrument
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type