Device Classification Name |
sponge, ophthalmic
|
510(k) Number |
K011191 |
Device Name |
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES |
Applicant |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216
|
|
Applicant Contact |
DIANA TAYLOR |
Correspondent |
MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216
|
|
Correspondent Contact |
DIANA TAYLOR |
Regulation Number | 886.4790
|
Classification Product Code |
|
Date Received | 04/19/2001 |
Decision Date | 06/26/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|