Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K073000 |
Device Name |
LUMAPROBE |
Applicant |
CLAREBLEND, INC. |
675 PINE STREET |
ELGIN,
IL
60123
|
|
Applicant Contact |
JILL CREASY |
Correspondent |
CLAREBLEND, INC. |
675 PINE STREET |
ELGIN,
IL
60123
|
|
Correspondent Contact |
JILL CREASY |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/24/2007 |
Decision Date | 10/01/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|