510(k) Number |
K073210 |
Device Name |
MODIFICATION TO: T-PORT HP INFUSION PORT |
Applicant |
PFM MEDICAL, INC |
2605 TEMPLE HEIGHTS DRIVE |
SUITE A |
OCEANSIDE,
CA
92056
|
|
Applicant Contact |
SALVADORE PALOMARES |
Correspondent |
PFM MEDICAL, INC |
2605 TEMPLE HEIGHTS DRIVE |
SUITE A |
OCEANSIDE,
CA
92056
|
|
Correspondent Contact |
SALVADORE PALOMARES |
Classification Product Code |
|
Date Received | 11/14/2007 |
Decision Date | 12/12/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|