Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K833961 |
Device Name |
I/A PLUS PAK SURGICAL SYSTEM |
Applicant |
|
Correspondent |
|
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 11/16/1983 |
Decision Date | 03/12/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|