Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K883986 |
Device Name |
CRIS ADAPTER |
Applicant |
Y |
P.O. BOX 85335 |
SAN DIEGO,
CA
92138 -5335
|
|
Applicant Contact |
KIMBERLY M CARLSON |
Correspondent |
Y |
P.O. BOX 85335 |
SAN DIEGO,
CA
92138 -5335
|
|
Correspondent Contact |
KIMBERLY M CARLSON |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/20/1988 |
Decision Date | 02/24/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|