Device Classification Name |
Light, Surgical, Ceiling Mounted
|
510(k) Number |
K922836 |
Device Name |
CHROMOPHARE |
Applicant |
BERCHTOLD HOLDING GMBH |
LUDWIGSTALER STR. 25 |
TUTTLINGEN,
DE
D-78532
|
|
Applicant Contact |
DAVID N BULMAN |
Correspondent |
BERCHTOLD HOLDING GMBH |
LUDWIGSTALER STR. 25 |
TUTTLINGEN,
DE
D-78532
|
|
Correspondent Contact |
DAVID N BULMAN |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 06/12/1992 |
Decision Date | 10/09/1992 |
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
|
Recalls |
CDRH Recalls
|