Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K770768 |
Device Name |
OPHTHALMOSCOPE, MODEL #11100 |
Applicant |
WELCH ALLYN, INC. |
Skaneateles Falls |
Skaneateles,
NY
13153
|
|
Applicant Contact |
Richard W. Newman |
Correspondent |
WELCH ALLYN, INC. |
Skaneateles Falls |
Skaneateles,
NY
13153
|
|
Correspondent Contact |
Richard W. Newman |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 04/28/1977 |
Decision Date | 05/06/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|