Device Classification Name |
light, surgical, ceiling mounted
|
510(k) Number |
K965130 |
Device Name |
CHROMOPHARE |
Applicant |
BERCHTOLD HOLDING GMBH |
LUDWIGSTALER STR. 25 |
TUTTLINGEN,
DE
D-78532
|
|
Applicant Contact |
W. HILL |
Correspondent |
BERCHTOLD HOLDING GMBH |
LUDWIGSTALER STR. 25 |
TUTTLINGEN,
DE
D-78532
|
|
Correspondent Contact |
W. HILL |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 12/23/1996 |
Decision Date | 07/14/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|