The following data is part of a premarket notification filed by J. Mortia Usa, Inc. with the FDA for Ls Oil.
| Device ID | K173920 |
| 510k Number | K173920 |
| Device Name: | LS OIL |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | J. Mortia USA, Inc. 9 Mason Irvine, CA 92618 |
| Contact | Keith A. Barritt |
| Correspondent | Keith A. Barritt Fish & Richardson P.C. 1000 Maine Avenue S.W., Suite 1000 Washington, DC 20024 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-22 |
| Decision Date | 2018-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887919762164 | K173920 | 000 |