Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K003553 |
Device Name |
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DRIVE, BLDG 2, |
MAIL CODE 226 |
FRANKLIN LAKES,
NJ
07417
|
|
Applicant Contact |
GREGORY W MORGAN |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DRIVE, BLDG 2, |
MAIL CODE 226 |
FRANKLIN LAKES,
NJ
07417
|
|
Correspondent Contact |
GREGORY W MORGAN |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 11/17/2000 |
Decision Date | 03/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|