Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K982587 |
Device Name |
MPS FIXED FLOW RATE SET |
Applicant |
MEDICAL PRODUCT SPECIALISTS |
499 NIBUS ST., SUITE E |
BREA,
CA
92821
|
|
Applicant Contact |
DAN HYUN |
Correspondent |
MEDICAL PRODUCT SPECIALISTS |
499 NIBUS ST., SUITE E |
BREA,
CA
92821
|
|
Correspondent Contact |
DAN HYUN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 07/24/1998 |
Decision Date | 08/24/1998 |
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
|
|
|