The following data is part of a premarket notification filed by Sciencity Co., Ltd with the FDA for Mitra-lift.
| Device ID | K103812 |
| 510k Number | K103812 |
| Device Name: | MITRA-LIFT |
| Classification | Ring, Annuloplasty |
| Applicant | SCIENCITY CO., LTD 325 N. PUENTE ST. UNIT B Brea, CA 92821 |
| Contact | Joyce Bang |
| Correspondent | Joyce Bang SCIENCITY CO., LTD 325 N. PUENTE ST. UNIT B Brea, CA 92821 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-29 |
| Decision Date | 2011-05-18 |
| Summary: | summary |