Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K862130 |
Device Name |
COMFORT-SET* I.V. CATHETER PLACEMENT UNIT. |
Applicant |
MENLO CARE, INC. |
1350 WILLOW RD. |
MENLO PARK,
CA
94025 -1516
|
|
Applicant Contact |
DWAYNE E HARDY |
Correspondent |
MENLO CARE, INC. |
1350 WILLOW RD. |
MENLO PARK,
CA
94025 -1516
|
|
Correspondent Contact |
DWAYNE E HARDY |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 06/04/1986 |
Decision Date | 08/14/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|