Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K894512 |
Device Name |
PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS |
Applicant |
INTL. OPHTHALMIC INDUSTRIES CORP. |
54 BAY STATE RD. |
WESTON,
MA
02193
|
|
Applicant Contact |
HILLARD W WELCH |
Correspondent |
INTL. OPHTHALMIC INDUSTRIES CORP. |
54 BAY STATE RD. |
WESTON,
MA
02193
|
|
Correspondent Contact |
HILLARD W WELCH |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 07/19/1989 |
Decision Date | 10/17/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|