Device Classification Name |
Laser, Ent Microsurgical Carbon-Dioxide
|
510(k) Number |
K841860 |
Device Name |
CO2 SURGICAL LASER SYSTEM XML-10 |
Applicant |
XANAR, INC. |
2868 JANITELL RD. |
COLORADO SPRINGS,
CO
80906
|
|
Applicant Contact |
DALTON |
Correspondent |
XANAR, INC. |
2868 JANITELL RD. |
COLORADO SPRINGS,
CO
80906
|
|
Correspondent Contact |
DALTON |
Regulation Number | 874.4500
|
Classification Product Code |
|
Date Received | 05/04/1984 |
Decision Date | 11/08/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|