Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K090281 |
Device Name |
ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES |
Applicant |
ACCUTECH MEDICAL TECHNOLOGIES, INC. |
3637 BERNAL AVE |
PLEASANTON,
CA
94566
|
|
Applicant Contact |
ANNE WORDEN |
Correspondent |
ACCUTECH MEDICAL TECHNOLOGIES, INC. |
3637 BERNAL AVE |
PLEASANTON,
CA
94566
|
|
Correspondent Contact |
ANNE WORDEN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/05/2009 |
Decision Date | 03/04/2009 |
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
|