Device Classification Name |
tubing, fluid delivery
|
510(k) Number |
K883718 |
Device Name |
MERIT HI-FLEX(TM) |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
79 WEST 4500 SOUTH |
SUITE 9 |
SALT LAKE CITY,
UT
84107
|
|
Applicant Contact |
P LAMPROPOULOS |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
79 WEST 4500 SOUTH |
SUITE 9 |
SALT LAKE CITY,
UT
84107
|
|
Correspondent Contact |
P LAMPROPOULOS |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 08/31/1988 |
Decision Date | 01/30/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|