Device Classification Name |
Accessories, Soft Lens Products
|
510(k) Number |
K863346 |
Device Name |
PROFESSIONAL DISINFECTION SYSTEM (PDS) |
Applicant |
CIBA VISION CARE |
P.O. BOX 105069 |
ATLANTA,
GA
30348
|
|
Applicant Contact |
PAUL G STAPLETON |
Correspondent |
CIBA VISION CARE |
P.O. BOX 105069 |
ATLANTA,
GA
30348
|
|
Correspondent Contact |
PAUL G STAPLETON |
Regulation Number | 886.5928
|
Classification Product Code |
|
Date Received | 08/29/1986 |
Decision Date | 02/27/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|