Device Classification Name |
table, operating-room, electrical
|
510(k) Number |
K940616 |
Device Name |
SKYTRON ELITE 3500 TABLE |
Applicant |
SKYTRON, DIV. THE KMW GROUP, INC. |
5000 36TH ST S.E. |
P.O.BOX 888615 |
GRAND RAPIDS,
MI
49588 -8615
|
|
Applicant Contact |
DAVID M MEHNEY |
Correspondent |
SKYTRON, DIV. THE KMW GROUP, INC. |
5000 36TH ST S.E. |
P.O.BOX 888615 |
GRAND RAPIDS,
MI
49588 -8615
|
|
Correspondent Contact |
DAVID M MEHNEY |
Regulation Number | 878.4960
|
Classification Product Code |
|
Date Received | 02/14/1994 |
Decision Date | 06/13/1994 |
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
|
|
|