Device Classification Name |
Syringe, Piston
|
510(k) Number |
K042934 |
Device Name |
1BD SOLOSHOT IX SYRINGE |
Applicant |
BECTON DICKINSON & CO. |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Applicant Contact |
PETER ZURLO |
Correspondent |
BECTON DICKINSON & CO. |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Correspondent Contact |
PETER ZURLO |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 10/25/2004 |
Decision Date | 10/28/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Expedited Review |
Yes
|
Combination Product |
No
|
|
|