Device Classification Name |
Tube, Tracheostomy (W/Wo Connector)
|
510(k) Number |
K850446 |
Device Name |
TRACHEOSTOMY CARE KIT |
Applicant |
PACO RESEARCH CORP. |
ELLIS PHARMACEUTICAL CONSULTIN |
913 STATE ROAD |
PRINCETON,
NJ
08540
|
|
Applicant Contact |
LEVI ELLIS |
Correspondent |
PACO RESEARCH CORP. |
ELLIS PHARMACEUTICAL CONSULTIN |
913 STATE ROAD |
PRINCETON,
NJ
08540
|
|
Correspondent Contact |
LEVI ELLIS |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 02/05/1985 |
Decision Date | 03/11/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|