Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K831701 |
Device Name |
UNIVERSAL PACK |
Applicant |
ATLANTIC OPTICAL SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ATLANTIC OPTICAL SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 05/25/1983 |
Decision Date | 07/12/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|