The following data is part of a premarket notification filed by Degania Silicone Ltd with the FDA for Aquarius Gastrostomy Replacement Tube.
| Device ID | K143378 |
| 510k Number | K143378 |
| Device Name: | AQUARIUS Gastrostomy Replacement Tube |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | DEGANIA SILICONE LTD DEGANIA BET Degania Bet, IL 15130 |
| Contact | Zoya Lee |
| Correspondent | Zoya Lee DEGANIA SILICONE LTD DEGANIA BET Degania Bet, IL 15130 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-25 |
| Decision Date | 2014-12-29 |
| Summary: | summary |