Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K931550 |
Device Name |
EZ ADMINISTRATION SET |
Applicant |
Y |
P.O. BOX 85335 |
SAN DIEGO,
CA
92138 -5335
|
|
Applicant Contact |
JENNIFER S HANKARD |
Correspondent |
Y |
P.O. BOX 85335 |
SAN DIEGO,
CA
92138 -5335
|
|
Correspondent Contact |
JENNIFER S HANKARD |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 03/29/1993 |
Decision Date | 01/10/1994 |
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
|
|
|