Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K021475 |
Device Name |
BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET |
Applicant |
BD |
1 BECTON DR. MC 226 |
FRANKLIN LAKES,
NJ
07417
|
|
Applicant Contact |
PASQUALE AMATO |
Correspondent |
BD |
1 BECTON DR. MC 226 |
FRANKLIN LAKES,
NJ
07417
|
|
Correspondent Contact |
PASQUALE AMATO |
Regulation Number | 880.5570
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/08/2002 |
Decision Date | 07/19/2002 |
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
|
Recalls |
CDRH Recalls
|
|
|