510(k) K072997
K072997 is an FDA 510(k) premarket notification submitted by Neomed, Inc. for the device "NEOMED URINARY CATHETER". The FDA issued a decision of Substantially Equivalent on December 19, 2007. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Neomed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2007
- Date Received
- October 24, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type