The following data is part of a premarket notification filed by Liv International Usa, Inc. with the FDA for Liv Breast Self Examination Aid.
| Device ID | K070344 |
| 510k Number | K070344 |
| Device Name: | LIV BREAST SELF EXAMINATION AID |
| Classification | System, X-ray, Mammographic |
| Applicant | LIV INTERNATIONAL USA, INC. 5811 PARTRIDGE DRIVE SW Rochester, MN 55902 |
| Contact | Partick Gora |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-02-06 |
| Decision Date | 2007-03-08 |
| Summary: | summary |