Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K954238 |
Device Name |
SURGIN GENISIS HANDPIECE |
Applicant |
SURGIN SURGICAL INSTRUMENTATION, INC. |
327 BLACKLEY ST. |
TEMPLE CITY,
CA
91789 -3139
|
|
Applicant Contact |
GLENN A DUNKI-JACOBS |
Correspondent |
SURGIN SURGICAL INSTRUMENTATION, INC. |
327 BLACKLEY ST. |
TEMPLE CITY,
CA
91789 -3139
|
|
Correspondent Contact |
GLENN A DUNKI-JACOBS |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 09/11/1995 |
Decision Date | 12/08/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|