Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K070805 |
Device Name |
ULTRAWAVE II EX 1320 |
Applicant |
QUANTA SYSTEM, S.P.A. |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
QUANTA SYSTEM, S.P.A. |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/23/2007 |
Decision Date | 07/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|