FDA 510(k) Applications Submitted by JAMES PATRICK GARVEY II
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K132433 |
08/05/2013 |
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE |
ACCLARENT, INC. |
K963047 |
07/29/1996 |
AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) |
FENWICK HEARING INSTRUMENTS |
K140160 |
01/22/2014 |
RELIEVA SCOUT SINUS DILATION SYSTEM |
ACCLARENT, INC. |
K150172 |
01/26/2015 |
ACCLARENT SE Inflation Device |
ACCLARENT, INC. |
K171687 |
06/07/2017 |
Relieva SpinPlus Nav Balloon Sinuplasty System |
Acclarent, Inc. |
K171761 |
06/14/2017 |
ACCLARENT AERA Eustachian Tube Balloon Dilation System |
Acclarent, Inc. |
K182083 |
08/02/2018 |
Catalys Precision Laser System |
AMO Manufacturing USA, LLC |
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