| 510(k) Number |
K844458 |
| Device Name |
ND:YAG LASER PULMONARY OBSTRUCTION |
| Applicant |
| Endo Lase, Inc. |
| Attn: Jonathan S. Kahan |
| 815 Connecticut Ave. |
|
Washington,
DC
20006
|
|
| Applicant Contact |
JONATHAN S KAHAN |
| Correspondent |
| Endo Lase, Inc. |
| Attn: Jonathan S. Kahan |
| 815 Connecticut Ave. |
|
Washington,
DC
20006
|
|
| Correspondent Contact |
JONATHAN S KAHAN |
| Date Received | 11/15/1984 |
| Decision Date | 01/03/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|