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 |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent 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
|
|
|