Device Classification Name |
Anesthesia Conduction Kit
|
510(k) Number |
K012584 |
Device Name |
MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT |
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 | 868.5140
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/10/2001 |
Decision Date | 09/06/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|