| Device Classification Name |
Anesthesia Conduction Kit
|
| 510(k) Number |
K090995 |
| Device Name |
B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET |
| Applicant |
| B. Braun Medical, Inc. |
| 901 Marcon Blvd. |
|
Allentown,
PA
18109 -9341
|
|
| Applicant Contact |
LISA GIAQUINTO |
| Correspondent |
| B. Braun Medical, Inc. |
| 901 Marcon Blvd. |
|
Allentown,
PA
18109 -9341
|
|
| Correspondent Contact |
LISA GIAQUINTO |
| Regulation Number | 868.5140 |
| Classification Product Code |
|
| Date Received | 04/07/2009 |
| Decision Date | 08/14/2009 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|