Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K221518 |
Device Name |
NP Medical nCompass Extension Set with Stabilizing Base |
Applicant |
NP Medical |
101 Union Street |
Clinton,
MA
01510
|
|
Applicant Contact |
Krishna Govindarajan |
Correspondent |
NP Medical |
101 Union Street |
Clinton,
MA
01510
|
|
Correspondent Contact |
Krishna Govindarajan |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/25/2022 |
Decision Date | 11/03/2022 |
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
|
|
|