Device Classification Name |
lens, contact (other material) - daily
|
510(k) Number |
K943177 |
Device Name |
BOSTON(R) 7 - 30(ENFLUFOCON A) |
Applicant |
POLYMER TECHNOLOGY CORP. |
1400 N. GOODMAN ST. |
ROCHESTER,
NY
14692
|
|
Applicant Contact |
DEBRA L.B. KETCHUM |
Correspondent |
POLYMER TECHNOLOGY CORP. |
1400 N. GOODMAN ST. |
ROCHESTER,
NY
14692
|
|
Correspondent Contact |
DEBRA L.B. KETCHUM |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 07/01/1994 |
Decision Date | 08/25/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|