Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K120337 |
Device Name |
I-PORT ADVANCE INJECTION PORT |
Applicant |
UNOMEDICAL A/S |
AAHOLMVEJ 1-3 |
OSTED, LEJRE,
DK
4320
|
|
Applicant Contact |
SOREN MELSTED |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
WILLIAM SAMMONS |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 02/03/2012 |
Decision Date | 02/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|