Device Classification Name |
Table, Surgical With Orthopedic Accessories, Manual
|
510(k) Number |
K905816 |
Device Name |
ORTHOVISION TABLE |
Applicant |
AMERICAN STERILIZER CO. |
2424 WEST 23RD ST. |
P.O. BOX 620 |
ERIE,
PA
16514
|
|
Applicant Contact |
MICHAEL J ZMUDA |
Correspondent |
AMERICAN STERILIZER CO. |
2424 WEST 23RD ST. |
P.O. BOX 620 |
ERIE,
PA
16514
|
|
Correspondent Contact |
MICHAEL J ZMUDA |
Regulation Number | 878.4950
|
Classification Product Code |
|
Date Received | 12/28/1990 |
Decision Date | 03/06/1991 |
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
|