FDA 510(k) Applications Submitted by Zoya Lee
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K070124 |
01/16/2007 |
GASTROSTOMY REPLACEMENT TUBE, MODEL 253 |
DEGANIA SILICONE, LTD. |
| K131020 |
04/12/2013 |
TEMPERATURE SENSOR CATHETER |
DEGANIA SILICONE, LTD. |
| K151040 |
04/20/2015 |
Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer |
BIOMETRIX LTD. |
| K141631 |
06/18/2014 |
AQUARIUS EXTENSION FEEDING SET |
DEGANIA SILICONE, LTD. |
| K141753 |
06/30/2014 |
AQUARIUS NASAL FEEDING TUBE |
DEGANIA SILICONE, LTD. |
| K122030 |
07/11/2012 |
LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON |
DEGANIA SILICONE, LTD. |
| K152246 |
08/10/2015 |
Aquarius Stoma Measuring Device |
DEGANIA SILICONE LTD |
| K132686 |
08/28/2013 |
AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE |
DEGANIA SILICONE, LTD. |
| K063442 |
11/14/2006 |
ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR |
DEGANIA SILICONE, LTD. |
| K103371 |
11/17/2010 |
COUDE/ OR TIEMANN |
DEGANIA SILICONE, LTD. |
| K143378 |
11/25/2014 |
AQUARIUS Gastrostomy Replacement Tube |
DEGANIA SILICONE LTD |
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