Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K141403 |
Device Name |
LITHO DK30 |
Applicant |
QUANTA SYSTEM, S.P.A. |
VIA IV NOVEMBRE,116 |
SOLBIATE OLONA,
IT
21058
|
|
Applicant Contact |
Maurizio Bianchi |
Correspondent |
QUANTA SYSTEM, S.P.A. |
VIA IV NOVEMBRE,116 |
SOLBIATE OLONA,
IT
21058
|
|
Correspondent Contact |
Maurizio Bianchi |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 05/28/2014 |
Decision Date | 08/07/2014 |
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
|
|
|