The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Aquarius Nasal Feeding Tube.
Device ID | K141753 |
510k Number | K141753 |
Device Name: | AQUARIUS NASAL FEEDING TUBE |
Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
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 | PIF |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-30 |
Decision Date | 2014-10-16 |
Summary: | summary |