The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Low Profile Gastrostomy Feeding Tube Or Gastrotomey Button.
| Device ID | K122030 |
| 510k Number | K122030 |
| Device Name: | LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | DEGANIA SILICONE, LTD. KIBBUTZ DEGANIA BET Emek Hayarden, IL 15130 |
| Contact | Zoya Lee |
| Correspondent | Zoya Lee DEGANIA SILICONE, LTD. KIBBUTZ 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 | 2012-07-11 |
| Decision Date | 2012-09-05 |