Device Classification Name |
Light, Surgical, Ceiling Mounted
|
510(k) Number |
K904965 |
Device Name |
SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 |
Applicant |
SMITH & NEPHEW EQUIPMENT GROUP |
1920 A. JEFFERSON AVE. |
ST. LOUIS,
MO
63104
|
|
Applicant Contact |
KEVIN RANDICH |
Correspondent |
SMITH & NEPHEW EQUIPMENT GROUP |
1920 A. JEFFERSON AVE. |
ST. LOUIS,
MO
63104
|
|
Correspondent Contact |
KEVIN RANDICH |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 11/05/1990 |
Decision Date | 01/16/1991 |
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
|