Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K882302 |
Device Name |
IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 |
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 | 06/02/1988 |
Decision Date | 07/12/1988 |
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
|
|
|