510(k) Premarket Notification Database
Device Classification Name |
pad, eye
|
510(k) Number | K904896 |
Device Name | EYE PAD |
Applicant |
ULTI-MED INTL., INC.
|
1688 glen ellyn rd. |
glendale heights,
IL
60139 |
|
Contact | david insco |
Regulation Number | 878.4440 |
Classification Product Code |
|
Date Received | 10/30/1990 |
Decision Date | 12/05/1990 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
General & Plastic Surgery
|
Review Advisory Committee |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|