Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K010888 |
Device Name |
SIDEPORT PINCH CLAMP DEVICE |
Applicant |
MEDIVICE SYSTEMS, LTD. |
BEIT HAPA'AMON (BOX 124) |
20 HATA'AS ST. |
KFAR SABA,
IL
44425
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
MEDIVICE SYSTEMS, LTD. |
BEIT HAPA'AMON (BOX 124) |
20 HATA'AS ST. |
KFAR SABA,
IL
44425
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 03/23/2001 |
Decision Date | 06/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|