The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Gastrostomy Replacement Tube, Model 253.
| Device ID | K070124 |
| 510k Number | K070124 |
| Device Name: | GASTROSTOMY REPLACEMENT TUBE, MODEL 253 |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| 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 | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-05-23 |