Device Classification Name |
knife, ophthalmic
|
510(k) Number |
K842647 |
Device Name |
CATARACT TRAY |
Applicant |
DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. |
POWELL,
TN
37849
|
|
Applicant Contact |
SUSAN HEVEY |
Correspondent |
DEROYAL INDUSTRIES, INC. |
200 DEBUSK LN. |
POWELL,
TN
37849
|
|
Correspondent Contact |
SUSAN HEVEY |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 07/10/1984 |
Decision Date | 05/09/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|