Device Classification Name |
Source, Carrier, Fiberoptic Light
|
510(k) Number |
K904470 |
Device Name |
SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE |
Applicant |
SUMMIT TECHNOLOGY, INC. |
21 HICKORY DR. |
WALTHAM,
MA
02154
|
|
Applicant Contact |
KIMBERLEY DONEY |
Correspondent |
SUMMIT TECHNOLOGY, INC. |
21 HICKORY DR. |
WALTHAM,
MA
02154
|
|
Correspondent Contact |
KIMBERLEY DONEY |
Regulation Number | 874.4350
|
Classification Product Code |
|
Date Received | 10/01/1990 |
Decision Date | 12/24/1990 |
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
|
|
|