Device Classification Name |
Catheters, Suction, Tracheobronchial
|
510(k) Number |
K843797 |
Device Name |
STERILE SALINE SOLUTION |
Applicant |
PACO PHARMACEUTICAL SERVICES, INC. |
1200 PACO WAY |
BUILDING 19 |
LAKEWOOD,
NJ
08701
|
|
Correspondent |
PACO PHARMACEUTICAL SERVICES, INC. |
1200 PACO WAY |
BUILDING 19 |
LAKEWOOD,
NJ
08701
|
|
Regulation Number | 868.6810
|
Classification Product Code |
|
Date Received | 09/27/1984 |
Decision Date | 01/18/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|