Device Classification Name |
Laser, Ent Microsurgical Carbon-Dioxide
|
510(k) Number |
K872710 |
Device Name |
MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT |
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 | 874.4500
|
Classification Product Code |
|
Date Received | 07/07/1987 |
Decision Date | 09/24/1987 |
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
|
|
|