Device Classification Name |
laser, surgical, gynecologic
|
510(k) Number |
K861845 |
Device Name |
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE |
Applicant |
DIRECTED ENERGY, INC. |
11661 SAN VICENTE BLVD. |
SUITE 203 |
LOS ANGELES,
CA
90049
|
|
Applicant Contact |
EDWARD JOHANSEN |
Correspondent |
DIRECTED ENERGY, INC. |
11661 SAN VICENTE BLVD. |
SUITE 203 |
LOS ANGELES,
CA
90049
|
|
Correspondent Contact |
EDWARD JOHANSEN |
Regulation Number | 884.4550
|
Classification Product Code |
|
Date Received | 05/13/1986 |
Decision Date | 08/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|