Device Classification Name |
Tube, Tympanostomy
|
510(k) Number |
K953802 |
Device Name |
TYMPANOSTOMY TUBE |
Applicant |
BLUFF CITY MEDICAL TECHNOLOGIES, INC. |
5295 EAST SHELBY DR. |
MEMPHIS,
TN
38118
|
|
Applicant Contact |
ANTHONY D PRESCOTT |
Correspondent |
BLUFF CITY MEDICAL TECHNOLOGIES, INC. |
5295 EAST SHELBY DR. |
MEMPHIS,
TN
38118
|
|
Correspondent Contact |
ANTHONY D PRESCOTT |
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 08/07/1995 |
Decision Date | 10/24/1995 |
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
|
|
|