510(k) K152268
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 2015
- Date Received
- August 11, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urethral
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type