Device Classification Name |
light, surgical, ceiling mounted
|
510(k) Number |
K102758 |
Device Name |
TRULIGHT 5520 AND TRULIGHT 5320 |
Applicant |
TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG |
1046 LEGRAND BOULEVARD |
CHARLESTON,
SC
29492
|
|
Applicant Contact |
LINDSEY RONNENBERG |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
JEFF D RONGERO |
Regulation Number | 878.4580
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/23/2010 |
Decision Date | 10/26/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|