Device Classification Name |
tube, tympanostomy
|
510(k) Number |
K923353 |
Device Name |
VENTILATION TUBES W/ HYDROGEL COATING |
Applicant |
MICROBIO-MEDICS, INC. |
1710 SHELBY OAKS DR. |
SUITE #21 |
MEMPHIS,
TN
38134
|
|
Applicant Contact |
ANTHONY D PRESCOTT |
Correspondent |
MICROBIO-MEDICS, INC. |
1710 SHELBY OAKS DR. |
SUITE #21 |
MEMPHIS,
TN
38134
|
|
Correspondent Contact |
ANTHONY D PRESCOTT |
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 07/08/1992 |
Decision Date | 05/18/1993 |
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
|
|
|