Device Classification Name |
system, documentation, breast lesion
|
510(k) Number |
K181672 |
Device Name |
SureTouch Mobile Pressure Mapping System |
Applicant |
Sure Inc. |
1404 Granvia Altamira |
Palos Verdes Estates,
CA
90274
|
|
Applicant Contact |
David Ables |
Correspondent |
Certified Compliance Solutions |
11665 Avena Place Suite 203 |
San Diego,
CA
92128
|
|
Correspondent Contact |
Laurence Harvey |
Regulation Number | 884.2990
|
Classification Product Code |
|
Date Received | 06/25/2018 |
Decision Date | 06/28/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|