Device Classification Name |
Device, Intravascular Catheter Securement
|
510(k) Number |
K896046 |
Device Name |
VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE |
Applicant |
VITAPHORE CORP. |
1505 O'BRIEN DR. |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
SOPHIA PESOTCHINSKY |
Correspondent |
VITAPHORE CORP. |
1505 O'BRIEN DR. |
MENLO PARK,
CA
94025
|
|
Correspondent Contact |
SOPHIA PESOTCHINSKY |
Regulation Number | 880.5210 |
Classification Product Code |
|
Date Received | 10/17/1989 |
Decision Date | 01/11/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|