Device Classification Name |
laser, ent microsurgical carbon-dioxide
|
510(k) Number |
K860277 |
Device Name |
MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT |
Applicant |
BRITT CORP., INC. |
2231 SOUTH BARRINGTON AVE. |
LOS ANGELES,
CA
90064
|
|
Applicant Contact |
JEFFREY GREEN |
Correspondent |
BRITT CORP., INC. |
2231 SOUTH BARRINGTON AVE. |
LOS ANGELES,
CA
90064
|
|
Correspondent Contact |
JEFFREY GREEN |
Regulation Number | 874.4500
|
Classification Product Code |
|
Date Received | 01/27/1986 |
Decision Date | 05/06/1986 |
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
|
|
|