Device Classification Name |
Products, Contact Lens Care, Rigid Gas Permeable
|
510(k) Number |
K974466 |
Device Name |
BOSTON ADVANCE CLEANER |
Applicant |
POLYMER TECHNOLOGY CORP. |
1400 N. GOODMAN ST. |
ROCHESTER,
NY
14692
|
|
Applicant Contact |
DOGULAS J FORTUNATO |
Correspondent |
POLYMER TECHNOLOGY CORP. |
1400 N. GOODMAN ST. |
ROCHESTER,
NY
14692
|
|
Correspondent Contact |
DOGULAS J FORTUNATO |
Regulation Number | 886.5918
|
Classification Product Code |
|
Date Received | 11/26/1997 |
Decision Date | 02/19/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|