Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K193131 |
Device Name |
BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle |
Applicant |
Becton, Dickinson and Company |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Applicant Contact |
Murtaza Rana |
Correspondent |
Becton, Dickinson and Company |
1 Becton Drive |
Franklin Lakes,
NJ
07417
|
|
Correspondent Contact |
Murtaza Rana |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 11/12/2019 |
Decision Date | 09/29/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|