| Device Classification Name |
sleeve, limb, compressible
|
|---|
| 510(K) Number |
K121145 |
|---|
| Model |
3000 SERIES
|
| Device Name |
RENU MEDICAL RSPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME |
|---|
| Applicant |
| RENU MEDICAL, INC. |
| 9800 evergreen way |
|
everett,
WA
98204
|
|
| Contact |
bruce pierson |
| Regulation Number | 870.5800
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/16/2012 |
|---|
| Decision Date | 06/12/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Cardiovascular
|
|---|
| Review Advisory Committee |
Cardiovascular
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
