Device Classification Name |
Syringe, Piston
|
510(k) Number |
K023752 |
Device Name |
BD INTEGRA SYRINGE |
Applicant |
BD |
ONE BECTON DRIVE MC226 |
FRANKLIN LAKES,
NJ
07417
|
|
Applicant Contact |
PASQUALE AMATO |
Correspondent |
BD |
ONE BECTON DRIVE MC226 |
FRANKLIN LAKES,
NJ
07417
|
|
Correspondent Contact |
PASQUALE AMATO |
Regulation Number | 880.5860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/08/2002 |
Decision Date | 02/07/2003 |
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
|
|
|