510(k) K062112
K062112 is an FDA 510(k) premarket notification submitted by Sunmed, Inc. for the device "SUNMED FOLEY CATHETERS". The FDA issued a decision of Substantially Equivalent on June 4, 2007. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Sunmed, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 2007
- Date Received
- July 24, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Retention Type, Balloon
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type