510(k) K103371
K103371 is an FDA 510(k) premarket notification submitted by Degania Silicone , Ltd. for the device "COUDE/ OR TIEMANN". The FDA issued a decision of Substantially Equivalent on March 11, 2011. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Degania Silicone , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2011
- Date Received
- November 17, 2010
- 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