Device Classification Name |
Light, Surgical, Ceiling Mounted
|
510(k) Number |
K984611 |
Device Name |
DRAGER SOLA SERIES, MODELS 1000/700/500/300 |
Applicant |
DRAGER MEDIZINTECHNIK GMBH |
53/55 MOISLINGER ALLEE |
LUEBECK,
DE
D-23542
|
|
Applicant Contact |
FRANK CLANZETT |
Correspondent |
DRAGER MEDIZINTECHNIK GMBH |
53/55 MOISLINGER ALLEE |
LUEBECK,
DE
D-23542
|
|
Correspondent Contact |
FRANK CLANZETT |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 12/29/1998 |
Decision Date | 03/29/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|