Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K091320 |
Device Name |
SPECTRA SP II, SPECTRA DENTA II |
Applicant |
LUTRONIC CORPORATION |
5 TIMBER LANE |
NORTH READING,
MA
01864
|
|
Applicant Contact |
MAUREEN O'CONNELL |
Correspondent |
LUTRONIC CORPORATION |
5 TIMBER LANE |
NORTH READING,
MA
01864
|
|
Correspondent Contact |
MAUREEN O'CONNELL |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 05/05/2009 |
Decision Date | 08/19/2009 |
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
|