Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K171957 |
Device Name |
MaxZero Extension Sets with Needless Connector |
Applicant |
Carefusion 303 Inc. |
10020 Pacific Mesa Blvd |
San Diego,
CA
92121
|
|
Applicant Contact |
Viviana Lai |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 06/29/2017 |
Decision Date | 07/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|