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 |