| 510(k) Number |
K862954 |
| Device Name |
LASER PLUME FILTERS |
| Applicant |
| Lifestream Int'L, Inc. |
| 525 Julie Rivers Dr. |
| Suite 100 |
|
Sugar Land,
TX
77478
|
|
| Applicant Contact |
MIKE BARBOUR |
| Correspondent |
| Lifestream Int'L, Inc. |
| 525 Julie Rivers Dr. |
| Suite 100 |
|
Sugar Land,
TX
77478
|
|
| Correspondent Contact |
MIKE BARBOUR |
| Date Received | 08/05/1986 |
| Decision Date | 08/14/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|