The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Aquarius Low Profile Gastrostomy Feeding Tube.
| Device ID | K132686 |
| 510k Number | K132686 |
| Device Name: | AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE |
| 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 - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-28 |
| Decision Date | 2014-05-12 |
| Summary: | summary |