Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K120573 |
Device Name |
MEDART 620 |
Applicant |
MEDART A/S |
2, PARK PAVILIONS, CLOS LLYN |
CWM, ENTERPRISE PARK |
SWANSEA,
GB
SA6 8QY
|
|
Applicant Contact |
DARREN THOMAS |
Correspondent |
MEDART A/S |
2, PARK PAVILIONS, CLOS LLYN |
CWM, ENTERPRISE PARK |
SWANSEA,
GB
SA6 8QY
|
|
Correspondent Contact |
DARREN THOMAS |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/27/2012 |
Decision Date | 06/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|