The following data is part of a premarket notification filed by Sure Inc. with the FDA for Suretouch Mobile Pressure Mappring System.
| Device ID | K181672 |
| 510k Number | K181672 |
| Device Name: | SureTouch Mobile Pressure Mappring System |
| Classification | System, Documentation, Breast Lesion |
| Applicant | Sure Inc. 1404 Granvia Altamira Palos Verdes Estates, CA 90274 |
| Contact | David Ables |
| Correspondent | Laurence Harvey Certified Compliance Solutions 11665 Avena Place Suite 203 San Diego, CA 92128 |
| Product Code | NKA |
| CFR Regulation Number | 884.2990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-25 |
| Decision Date | 2019-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000501729 | K181672 | 000 |
| 00860000501712 | K181672 | 000 |