Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K180843 |
Device Name |
HIgH-Flo Super26 Subcutaneous Needle Sets |
Applicant |
Repro-Med Systems, Inc. dba RMS Medical Products |
24 Carpenter Road |
Chester,
NY
10918
|
|
Applicant Contact |
Cynthia Lacatena |
Correspondent |
Repro-Med Systems, Inc. dba RMS Medical Products |
24 Carpenter Road |
Chester,
NY
10918
|
|
Correspondent Contact |
Cynthia Lacatena |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/02/2018 |
Decision Date | 04/04/2019 |
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
|
|
|