Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K912902 |
Device Name |
PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE |
Applicant |
SITE MICROSURGICAL SYSTEMS, INC. |
135 GIBRALTAR RD. |
HORSHAM,
PA
19044
|
|
Applicant Contact |
JAMES K MCCRACKEN |
Correspondent |
SITE MICROSURGICAL SYSTEMS, INC. |
135 GIBRALTAR RD. |
HORSHAM,
PA
19044
|
|
Correspondent Contact |
JAMES K MCCRACKEN |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 07/02/1991 |
Decision Date | 12/17/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|