The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Aquarius Extension Feeding Set.
| Device ID | K141631 |
| 510k Number | K141631 |
| Device Name: | AQUARIUS EXTENSION FEEDING SET |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | DEGANIA SILICONE, LTD. KIBBUTZ DEGANIA BET Emek Hayarden, IL 1513000 |
| Contact | Zoya Lee |
| Correspondent | Zoya Lee DEGANIA SILICONE, LTD. KIBBUTZ DEGANIA BET Emek Hayarden, IL 1513000 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-18 |
| Decision Date | 2014-07-28 |
| Summary: | summary |