Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K940775 |
Device Name |
INJECTION CAP |
Applicant |
MEDRON, INC. |
3614 WEST 2100 SOUTH |
SALT LAKE CITY,
UT
84120
|
|
Applicant Contact |
RON WORTLEY |
Correspondent |
MEDRON, INC. |
3614 WEST 2100 SOUTH |
SALT LAKE CITY,
UT
84120
|
|
Correspondent Contact |
RON WORTLEY |
Regulation Number | 880.5200 |
Classification Product Code |
|
Date Received | 02/22/1994 |
Decision Date | 06/15/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|