The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for All Silicone Foley Catheter, 2-way, 3-way, With Temperature Sensor.
| Device ID | K063442 |
| 510k Number | K063442 |
| Device Name: | ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR |
| 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 | 2006-11-14 |
| Decision Date | 2007-03-26 |