Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K880411 |
Device Name |
DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE |
Applicant |
DEY LABORATORIES, INC. |
1011 DETROIT AVE. |
CONCORD,
CA
94518
|
|
Applicant Contact |
RAFF, PHD |
Correspondent |
DEY LABORATORIES, INC. |
1011 DETROIT AVE. |
CONCORD,
CA
94518
|
|
Correspondent Contact |
RAFF, PHD |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 02/01/1988 |
Decision Date | 02/29/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|