Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K912739 |
Device Name |
SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH 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 | 06/21/1991 |
Decision Date | 08/28/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|