Device Classification Name |
set, blood transfusion
|
510(k) Number |
K000685 |
Device Name |
CHARTER MEDICAL NEONATAL SYRINGE SET |
Applicant |
CHARTER MEDICAL, LTD. |
1805 SWARTHMORE AVE. |
LAKEWOOD,
NJ
08701
|
|
Applicant Contact |
K. ALICE PREVILLE |
Correspondent |
CHARTER MEDICAL, LTD. |
1805 SWARTHMORE AVE. |
LAKEWOOD,
NJ
08701
|
|
Correspondent Contact |
K. ALICE PREVILLE |
Regulation Number | 880.5440
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/29/2000 |
Decision Date | 08/15/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|