| Device Classification Name |
drape, surgical
|
| 510(k) Number |
K141438 |
| Device Name |
WHITNEY MEDICAL SOLUTIONS ESHIELD |
| Applicant |
| WHITNEY MEDICAL SOLUTIONS |
| 6153c west mulford street |
|
niles,
IL
60714
|
|
| Applicant Contact |
saagar patel |
| Correspondent |
| REGULATORY TECHNOLOGY SERVICES, LLC |
| 1394 25th street, nw |
|
buffalo,
MN
55313
|
|
| Correspodent Contact |
saagar patel |
| Regulation Number | 878.4370
|
| Classification Product Code |
|
| Date Received | 05/30/2014 |
| Decision Date | 08/14/2014 |
| Decision |
substantially equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General Hospital
|
| summary |
summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
Yes
|
| Combination Product |
No
|
|
|