Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K041345 |
Device Name |
PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES |
Applicant |
MEDIX, INC. |
6250 SHIER RINGS ROAD |
DUBLIN,
OH
43016
|
|
Applicant Contact |
BARBARA LAW |
Correspondent |
MEDIX, INC. |
6250 SHIER RINGS ROAD |
DUBLIN,
OH
43016
|
|
Correspondent Contact |
BARBARA LAW |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 05/20/2004 |
Decision Date | 07/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|