Device Classification Name |
lens, contact (other material) - daily
|
510(k) Number |
K970698 |
Device Name |
BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS |
Applicant |
POLYMER TECHNOLOGY CORP. |
1400 N. GOODMAN ST. |
ROCHESTER,
NY
14692
|
|
Applicant Contact |
DOUGLAS J FORTUNATO |
Correspondent |
POLYMER TECHNOLOGY CORP. |
1400 N. GOODMAN ST. |
ROCHESTER,
NY
14692
|
|
Correspondent Contact |
DOUGLAS J FORTUNATO |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 02/25/1997 |
Decision Date | 05/06/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|