Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K001102 |
Device Name |
PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E |
Applicant |
RD MEDICAL MFG., INC. |
BO. FULLADOSA |
CULEBRA,
PR
00775
|
|
Applicant Contact |
CARLOS A RODRIGUEZ-GARCIA |
Correspondent |
RD MEDICAL MFG., INC. |
BO. FULLADOSA |
CULEBRA,
PR
00775
|
|
Correspondent Contact |
CARLOS A RODRIGUEZ-GARCIA |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/05/2000 |
Decision Date | 04/20/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|