Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K001704 |
Device Name |
ATHOS |
Applicant |
COSMOS MEDICAL TECHNOLOGY |
42230 ZEVO DR. |
TEMECULA,
CA
92590
|
|
Applicant Contact |
JOHN CLARK |
Correspondent |
COSMOS MEDICAL TECHNOLOGY |
42230 ZEVO DR. |
TEMECULA,
CA
92590
|
|
Correspondent Contact |
JOHN CLARK |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 06/05/2000 |
Decision Date | 08/31/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|