The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Coude/ Or Tiemann.
| Device ID | K103371 |
| 510k Number | K103371 |
| Device Name: | COUDE/ OR TIEMANN |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden, IL 15130 |
| Contact | Zoya Lee |
| Correspondent | Zoya Lee DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden, IL 15130 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-17 |
| Decision Date | 2011-03-11 |