Device Classification Name |
ophthalmoscope, battery-powered
|
510(k) Number |
K896072 |
Device Name |
D.L. SCOPE OPHTHALMOSCOPE |
Applicant |
NORTH AMERICAN MEDICAL PRODUCTS, INC. |
6 WHITE FIR DR. |
LOUDONVILLE,
NY
12211
|
|
Applicant Contact |
ARTHUR GIANAKOS |
Correspondent |
NORTH AMERICAN MEDICAL PRODUCTS, INC. |
6 WHITE FIR DR. |
LOUDONVILLE,
NY
12211
|
|
Correspondent Contact |
ARTHUR GIANAKOS |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 10/19/1989 |
Decision Date | 11/27/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|