Device Classification Name |
laser, neodymium:yag, pulmonary surgery
|
510(k) Number |
K875104 |
Device Name |
SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE |
Applicant |
LASERGUIDE |
51 SANTA FELICIA DR. |
SANTA BARBARA,
CA
93117
|
|
Applicant Contact |
ROBERT C MICHAELS |
Correspondent |
LASERGUIDE |
51 SANTA FELICIA DR. |
SANTA BARBARA,
CA
93117
|
|
Correspondent Contact |
ROBERT C MICHAELS |
Regulation Number | 874.4500
|
Classification Product Code |
|
Date Received | 12/18/1987 |
Decision Date | 02/02/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|