The following data is part of a premarket notification filed by Hrs Co., Ltd. with the FDA for Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite.
| Device ID | K181604 |
| 510k Number | K181604 |
| Device Name: | Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite |
| Classification | Material, Impression |
| Applicant | HRS Co., Ltd. 7, Chupalsandan 2-gil, Paengseong-eup, Pyeongtaek-si Gyeonggi-do, KR 17998 |
| Contact | Seunghwan Go |
| Correspondent | Yang Ho Dong Onbix Corporation #821 Samil Plaza, 14 Dogok-ro 1-gil, Gangnam-gu Seul, KR 06253 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-19 |
| Decision Date | 2018-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809746990079 | K181604 | 000 |
| 08809746990062 | K181604 | 000 |
| 08809746990055 | K181604 | 000 |