510(k) K013360
K013360 is an FDA 510(k) premarket notification submitted by Neoseed Technology,Llc for the device "DFINER UROLOGICAL CATHETER". The FDA issued a decision of Substantially Equivalent on February 20, 2002. The device falls under product code FGI (Catheter, Urethrographic, Male), a Class II device regulated under 21 CFR 876.5130.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 2002
- Date Received
- October 10, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urethrographic, Male
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type