| Device Classification Name |
Laser, Neodymium:Yag, Pulmonary Surgery
|
| 510(k) Number |
K874254 |
| Device Name |
ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS |
| Applicant |
| Minnesota Laser Corp. |
| 2452 N. Prior Ave. |
|
Roseville,
MN
55113
|
|
| Applicant Contact |
CONSTANCE G BUNDY |
| Correspondent |
| Minnesota Laser Corp. |
| 2452 N. Prior Ave. |
|
Roseville,
MN
55113
|
|
| Correspondent Contact |
CONSTANCE G BUNDY |
| Regulation Number | 874.4500 |
| Classification Product Code |
|
| Date Received | 10/20/1987 |
| Decision Date | 03/04/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ear Nose & Throat
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|