Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K153293 |
Device Name |
Extension Set |
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 | 11/13/2015 |
Decision Date | 04/06/2016 |
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
|
Recalls |
CDRH Recalls
|
|
|