Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K872611 |
Device Name |
SOLOS EYESITE CAP SLEEVE |
Applicant |
SOLOS OPHTHALMOLOGY |
6191 ATLANTIC BLVD. |
NORCROSS,
GA
30071
|
|
Applicant Contact |
STEPHEN HOLMES |
Correspondent |
SOLOS OPHTHALMOLOGY |
6191 ATLANTIC BLVD. |
NORCROSS,
GA
30071
|
|
Correspondent Contact |
STEPHEN HOLMES |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 07/06/1987 |
Decision Date | 08/10/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|