Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K991788 |
Device Name |
SALTER LABS PEP DEVICE |
Applicant |
SALTER LABS |
100 WEST SYCAMORE RD. |
ARVIN,
CA
93203
|
|
Applicant Contact |
DUANE KAZAL |
Correspondent |
SALTER LABS |
100 WEST SYCAMORE RD. |
ARVIN,
CA
93203
|
|
Correspondent Contact |
DUANE KAZAL |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 05/25/1999 |
Decision Date | 08/06/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|