Device Classification Name |
Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
|
510(k) Number |
K855146 |
Device Name |
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL |
Applicant |
LASERSCOPE |
3350 SCOTT BLVD., BLDG.30 |
SANTA CLARA,
CA
95051
|
|
Applicant Contact |
ROSS ERICKSON |
Correspondent |
LASERSCOPE |
3350 SCOTT BLVD., BLDG.30 |
SANTA CLARA,
CA
95051
|
|
Correspondent Contact |
ROSS ERICKSON |
Regulation Number | 874.4490
|
Classification Product Code |
|
Date Received | 12/24/1985 |
Decision Date | 04/11/1986 |
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
|
|
|