Device Classification Name |
pad, eye
|
510(k) Number |
K850005 |
Device Name |
VISOPROTECT OCCULAR SHIELD |
Applicant |
M.S.G. HEALTH SYSTEMS, INC. |
BOX 3324 WOODSIDE RD. |
BRUNSWICK,
ME
04011
|
|
Applicant Contact |
MAURICE GHALY |
Correspondent |
M.S.G. HEALTH SYSTEMS, INC. |
BOX 3324 WOODSIDE RD. |
BRUNSWICK,
ME
04011
|
|
Correspondent Contact |
MAURICE GHALY |
Regulation Number | 878.4440
|
Classification Product Code |
|
Date Received | 01/02/1985 |
Decision Date | 03/20/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|