Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K944660 |
Device Name |
ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY |
Applicant |
NEOSTAR MEDICAL TECHNOLOGIES, INC. |
100 ROSS RD. |
KING OF PRUSSIA,
PA
19406
|
|
Applicant Contact |
TROY M HARMON |
Correspondent |
NEOSTAR MEDICAL TECHNOLOGIES, INC. |
100 ROSS RD. |
KING OF PRUSSIA,
PA
19406
|
|
Correspondent Contact |
TROY M HARMON |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 09/21/1994 |
Decision Date | 03/13/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|