Device Classification Name |
pad, eye
|
510(k) Number |
K850099 |
Device Name |
VISOPROTECT: OCCULAR SHIELD |
Applicant |
ROCKWAY ENTERPRISES, INC. |
P.O. BOX 8 |
ST GEORGE,
ME
04857
|
|
Applicant Contact |
ONAT |
Correspondent |
ROCKWAY ENTERPRISES, INC. |
P.O. BOX 8 |
ST GEORGE,
ME
04857
|
|
Correspondent Contact |
ONAT |
Regulation Number | 878.4440
|
Classification Product Code |
|
Date Received | 01/11/1985 |
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
|
|
|