Device Classification Name |
light, surgical, ceiling mounted
|
510(k) Number |
K063333 |
Device Name |
M3 |
Applicant |
MAVIG GMBH |
STAHLGRUBERRING 5 |
MUNCHEN,
DE
81829
|
|
Applicant Contact |
CHRISTIAN STOIAN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
JEFFERY D RONGERO |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 11/06/2006 |
Decision Date | 11/21/2006 |
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
|
|
|