510(k) K083358
K083358 is an FDA 510(k) premarket notification submitted by Farco Pharma GmbH for the device "LUBRICANO-ULTRASOUND". The FDA issued a decision of Substantially Equivalent on January 9, 2009. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570. Farco Pharma GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2009
- Date Received
- October 14, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Coupling, Ultrasound
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type