Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K212842 |
Device Name |
Microvolume Luer Access Device |
Applicant |
B. Braun Medical Inc. |
901 Marcon Blvd. |
Allentown,
PA
18109 -9341
|
|
Applicant Contact |
Kimberly Smith |
Correspondent |
B. Braun Medical Inc. |
901 Marcon Blvd. |
Allentown,
PA
18109 -9341
|
|
Correspondent Contact |
Kimberly Smith |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/07/2021 |
Decision Date | 01/18/2022 |
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
|
|
|