Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K000125 |
Device Name |
JET PORT PLUS CATHETER SYSTEM |
Applicant |
CLINICAL PLASTIC PRODUCTS SA |
154 VIA LAMPARA |
RANCHO SANTA MARGARITA,
CA
92688
|
|
Applicant Contact |
SALVADORE F PALOMARES |
Correspondent |
CLINICAL PLASTIC PRODUCTS SA |
154 VIA LAMPARA |
RANCHO SANTA MARGARITA,
CA
92688
|
|
Correspondent Contact |
SALVADORE F PALOMARES |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 01/18/2000 |
Decision Date | 04/12/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|