Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K870671 |
Device Name |
PHACOTRON DAY PAK |
Applicant |
UNITED SURGICAL CORP. |
15500-A ROCKFIELD BLVD. |
IRVINE,
CA
92718
|
|
Applicant Contact |
TERRY F HERBECK |
Correspondent |
UNITED SURGICAL CORP. |
15500-A ROCKFIELD BLVD. |
IRVINE,
CA
92718
|
|
Correspondent Contact |
TERRY F HERBECK |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 02/19/1987 |
Decision Date | 04/06/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|