Device Classification Name |
laser, surgical, gynecologic
|
510(k) Number |
K851425 |
Device Name |
MODEL J25-25 WATT CO2 LASER |
Applicant |
BRITT CORP., INC. |
2231 SOUTH BARRINGTON AVE. |
LOS ANGELES,
CA
90064
|
|
Applicant Contact |
JOHN J MCDONALD |
Correspondent |
BRITT CORP., INC. |
2231 SOUTH BARRINGTON AVE. |
LOS ANGELES,
CA
90064
|
|
Correspondent Contact |
JOHN J MCDONALD |
Regulation Number | 884.4550
|
Classification Product Code |
|
Date Received | 04/10/1985 |
Decision Date | 11/12/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|