Device Classification Name |
Pad, Eye
|
510(k) Number |
K851906 |
Device Name |
SURGICAL EYE PACK |
Applicant |
XANMED CORP. |
815 CONNECTICUT AVENUE NW |
WASHINGTON ,
DC
20006 -
|
|
Applicant Contact |
DAVID B VANCE |
Correspondent |
XANMED CORP. |
815 CONNECTICUT AVENUE NW |
WASHINGTON ,
DC
20006 -
|
|
Correspondent Contact |
DAVID B VANCE |
Regulation Number | 878.4440
|
Classification Product Code |
|
Date Received | 05/01/1985 |
Decision Date | 05/21/1985 |
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
|
|
|