The following data is part of a premarket notification filed by Csm Implant with the FDA for Csm Submerged3-l Implant System.
| Device ID | K173141 |
| 510k Number | K173141 |
| Device Name: | CSM Submerged3-L Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CSM Implant B205 Techno B/D, 47 Gyeongdae-ro, 17gil, Buk-gu Daegu, KR 41566 |
| Contact | Sung Am Cho |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-09-19 |
| Summary: | summary |