Device Classification Name |
Lamp, Surgical
|
510(k) Number |
K010724 |
Device Name |
SOLA 700,SOLA 500, SOLA 300 |
Applicant |
DRAGER MEDIZINTECHNIK GMBH |
3135 QUARRY RD. |
TELFORD,
PA
18969
|
|
Applicant Contact |
JAMES J BRENNAN |
Correspondent |
DRAGER MEDIZINTECHNIK GMBH |
3135 QUARRY RD. |
TELFORD,
PA
18969
|
|
Correspondent Contact |
JAMES J BRENNAN |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 03/12/2001 |
Decision Date | 06/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|