Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K980829 |
Device Name |
3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP |
Applicant |
STERIPAK, LTD. |
140 LEGRAND AVE. |
NORTHVALE,
NJ
07647
|
|
Applicant Contact |
JASON A GROSS |
Correspondent |
STERIPAK, LTD. |
140 LEGRAND AVE. |
NORTHVALE,
NJ
07647
|
|
Correspondent Contact |
JASON A GROSS |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 03/04/1998 |
Decision Date | 06/02/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|