Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K864164 |
Device Name |
CRIS ADAPTED WITH VOLUME LIMITING BAG |
Applicant |
Y |
P.O. BOX 85335 |
SAN DIEGO,
CA
92138 -5335
|
|
Applicant Contact |
ROBERT J BARD |
Correspondent |
Y |
P.O. BOX 85335 |
SAN DIEGO,
CA
92138 -5335
|
|
Correspondent Contact |
ROBERT J BARD |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/23/1986 |
Decision Date | 12/16/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|