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543
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537
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490
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465
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510k Database
Manufacturers
US
R-Group Intl.
Medical Device Manufacturer
·
US , Gainesville , FL
R-Group Intl. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 1992
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - R-Group Intl.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 13, 2000
ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
K001233
·
FPA
General Hospital
·
240d
Cleared
Sep 18, 2000
ACTI-FLEX IV ADMINISTRATION SET
K001599
·
FPA
General Hospital
·
117d
Cleared
Nov 10, 1994
R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE
K940319
·
FPA
General Hospital
·
290d
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7
General Hospital
3
Cardiovascular
1
Obstetrics & Gynecology
1
General & Plastic Surgery
1
Anesthesiology
1