Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K033853 |
Device Name |
MODIFICATION TO V-CATH POLY PICC |
Applicant |
HDC CORP. |
628 GIBRALTAR CT. |
MILPITAS,
CA
95035
|
|
Applicant Contact |
EARL SMART |
Correspondent |
HDC CORP. |
628 GIBRALTAR CT. |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
EARL SMART |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/11/2003 |
Decision Date | 01/14/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|