Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K984590 |
Device Name |
0.9% SODIUM CHLORIDE FLUSH SYRINGE |
Applicant |
BAXTER HEALTHCARE CORP. |
RT. 120 & WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
MARCIA MARCONI |
Correspondent |
BAXTER HEALTHCARE CORP. |
RT. 120 & WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
MARCIA MARCONI |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/28/1998 |
Decision Date | 10/07/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|