Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K083207 |
Device Name |
ULTRAWAVE III EX 1320 |
Applicant |
QUANTA SYSTEM, S.P.A. |
VIA IV NOVEMBRE,116 |
SOLBIATE OLONA(VA),
IT
21058
|
|
Applicant Contact |
ISABELLA CARRER |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 10/31/2008 |
Decision Date | 11/14/2008 |
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
|
|
|