Device Classification Name |
instrument, ent manual surgical
|
510(k) Number |
K873044 |
Device Name |
POREX OTOLOGY INSTRUMENTS |
Applicant |
POREX MEDICAL |
500 BOHANNON RD. |
FAIRBURN,
GA
30213
|
|
Applicant Contact |
HOWARD A MERCER,PHD |
Correspondent |
POREX MEDICAL |
500 BOHANNON RD. |
FAIRBURN,
GA
30213
|
|
Correspondent Contact |
HOWARD A MERCER,PHD |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 08/04/1987 |
Decision Date | 09/04/1987 |
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
|
|
|