510(k) K990909
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1999
- Date Received
- March 18, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Irrigation, Urological
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type