Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K001599 |
Device Name |
ACTI-FLEX IV ADMINISTRATION SET |
Applicant |
R-GROUP INTL. |
2321 N.W. 66TH CT., SUITE W-4 |
GAINESVILLE,
FL
32653
|
|
Applicant Contact |
KERRY ANNE KAHN |
Correspondent |
R-GROUP INTL. |
2321 N.W. 66TH CT., SUITE W-4 |
GAINESVILLE,
FL
32653
|
|
Correspondent Contact |
KERRY ANNE KAHN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/24/2000 |
Decision Date | 09/18/2000 |
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
|
|
|