Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K062248 |
Device Name |
AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM |
Applicant |
NORTH AMERICAN CLINICAL LASERS, LTD. |
2755 SO. AMES WAY |
DENVER,
CO
80227
|
|
Applicant Contact |
GEOFFREY D SWANK |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
NEIL E DEVINE, JR. |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 08/03/2006 |
Decision Date | 08/17/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|