510(k) K080881
K080881 is an FDA 510(k) premarket notification submitted by Cure Medical, LLC for the device "CURE CATHETER CLOSED SYSTEM". The FDA issued a decision of Substantially Equivalent on June 11, 2008. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Cure Medical, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2008
- Date Received
- March 31, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Urological
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type