Device Classification Name |
Sponge, Ophthalmic
|
510(k) Number |
K897034 |
Device Name |
K-SPONGE |
Applicant |
KATENA PRODUCTS, INC. |
4 STEWART CT. |
DENVILLE,
NJ
07834
|
|
Applicant Contact |
KATE TIEDEMANN |
Correspondent |
KATENA PRODUCTS, INC. |
4 STEWART CT. |
DENVILLE,
NJ
07834
|
|
Correspondent Contact |
KATE TIEDEMANN |
Regulation Number | 886.4790
|
Classification Product Code |
|
Date Received | 12/18/1989 |
Decision Date | 02/15/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|