Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K940319 |
Device Name |
R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE |
Applicant |
R-GROUP INTL. |
P.O. BOX 7235 |
2321 NW 66TH COURT, SUITE W4 |
GAINESVILLE,
FL
32653
|
|
Applicant Contact |
MARK J KAHN |
Correspondent |
R-GROUP INTL. |
P.O. BOX 7235 |
2321 NW 66TH COURT, SUITE W4 |
GAINESVILLE,
FL
32653
|
|
Correspondent Contact |
MARK J KAHN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 01/24/1994 |
Decision Date | 11/10/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|