Device Classification Name |
Light, Surgical, Ceiling Mounted
|
510(k) Number |
K040735 |
Device Name |
ALM X'TEN (X10) SURGICAL LIGHT SYSTEM |
Applicant |
ALM S.A. |
1777 EAST HENRIETTA ROAD |
ROCHESTER,
NY
14623 -3133
|
|
Applicant Contact |
FREDERICK R CATT |
Correspondent |
ALM S.A. |
1777 EAST HENRIETTA ROAD |
ROCHESTER,
NY
14623 -3133
|
|
Correspondent Contact |
FREDERICK R CATT |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 03/22/2004 |
Decision Date | 05/21/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|