Device Classification Name |
Tube, Tympanostomy
|
510(k) Number |
K142282 |
FOIA Releasable 510(k) |
K142282
|
Device Name |
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) |
Applicant |
PRECEPTIS MEDICAL |
505 HIGHWAY 169 NORTH, #365 |
PLYMOUTH,
MN
55441
|
|
Applicant Contact |
KEITH LELAND |
Correspondent |
PRECEPTIS MEDICAL |
505 HIGHWAY 169 NORTH, #365 |
PLYMOUTH,
MN
55441
|
|
Correspondent Contact |
KEITH LELAND |
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 08/15/2014 |
Decision Date | 04/23/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02165384
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|