Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K083476 |
Device Name |
NOVEON MODEL LS1100-03 |
Applicant |
NOMIR MEDICAL TECHNOLOGIES, INC. |
307 WAVERLEY OAKS ROAD |
SUITE 109 |
WALTHAM,
MA
02452
|
|
Applicant Contact |
RICHARD F BURTT |
Correspondent |
NOMIR MEDICAL TECHNOLOGIES, INC. |
307 WAVERLEY OAKS ROAD |
SUITE 109 |
WALTHAM,
MA
02452
|
|
Correspondent Contact |
RICHARD F BURTT |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/24/2008 |
Decision Date | 12/22/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|