510(k) K082815
K082815 is an FDA 510(k) premarket notification submitted by Well Lead Medical Instruments for the device "WELL LEAD SILICONE AND LATEX FOLEY CATHETERS". The FDA issued a decision of Substantially Equivalent on October 8, 2008. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Well Lead Medical Instruments has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2008
- Date Received
- September 25, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Retention Type, Balloon
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type