Device Classification Name |
set, i.v. fluid transfer
|
510(k) Number |
K913804 |
Device Name |
EXCELSIOR SINGLE LEAD DISPENSING SET |
Applicant |
EXCEL MEDICAL, INC. |
P.O. BOX 1353 |
ASBURY PARK,
NJ
07712
|
|
Applicant Contact |
MARGARET LUMIA |
Correspondent |
EXCEL MEDICAL, INC. |
P.O. BOX 1353 |
ASBURY PARK,
NJ
07712
|
|
Correspondent Contact |
MARGARET LUMIA |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 08/26/1991 |
Decision Date | 02/11/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|