Device Classification Name |
tube, tympanostomy
|
510(k) Number |
K830228 |
FOIA Releasable 510(k) |
K830228
|
Device Name |
OTOLOGICAL VENTILATION TUBES-VARIOUS |
Applicant |
MICROMEDICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MICROMEDICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 01/24/1983 |
Decision Date | 03/07/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|