Device Classification Name |
lens, contact, polymethylmethacrylate, diagnostic
|
510(k) Number |
K971853 |
Device Name |
ENDOVIEW SPPHIRE LENS SET |
Applicant |
AMERICAN MEDICAL DEVICES, INC. |
1100 NORTHSIDE DR. |
ATLANTA,
GA
30318
|
|
Applicant Contact |
FRANK J TIGHE |
Correspondent |
AMERICAN MEDICAL DEVICES, INC. |
1100 NORTHSIDE DR. |
ATLANTA,
GA
30318
|
|
Correspondent Contact |
FRANK J TIGHE |
Regulation Number | 886.1385
|
Classification Product Code |
|
Date Received | 05/20/1997 |
Decision Date | 08/06/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|