FDA 510(k) Applications Submitted by KERI YEN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110097 |
01/13/2011 |
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
ACCLARENT, INC. |
| K110218 |
01/25/2011 |
INSPIRA AIR BALLOON DILATION SYSTEM |
ACCLARENT, INC. |
| K100577 |
03/01/2010 |
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
ACCLARENT, INC. |
| K090660 |
03/12/2009 |
AIRWAY BALLOON CATHETER INFLATION DEVICE |
ACCLARENT, INC. |
| K111875 |
07/01/2011 |
RELIEVA SPIN SINUS DILATION SYSTEM |
ACCLARENT, INC. |
| K061903 |
07/05/2006 |
RELIEVA SINUS BALLOON CATHETER |
ACCLARENT, INC. |
| K071845 |
07/05/2007 |
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A |
ACCLARENT, INC. |
| K082188 |
08/04/2008 |
TYMPANOSTOMY TUBE |
ACCLARENT, INC. |
| K072891 |
10/10/2007 |
SINUS SPACER |
ACCLARENT, INC. |
| K073041 |
10/29/2007 |
RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER |
ACCLARENT, INC. |
| K073276 |
11/21/2007 |
IONTOPHORESIS SYSTEM |
ACCLARENT, INC. |
| K083574 |
12/03/2008 |
RELIEVA STRATUS MICROFLOW SPACER |
ACCLARENT, INC. |
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