The following data is part of a premarket notification filed by Cybermed, Inc. with the FDA for Vimplant.
| Device ID | K053155 |
| 510k Number | K053155 |
| Device Name: | VIMPLANT |
| Classification | System, Image Processing, Radiological |
| Applicant | CYBERMED, INC. #504 SJ TECHNOVILLE, GASAN-DONG 60-19, GEUMCHEON-GU Seoul, KR 153-710 |
| Contact | Song Nak Choi |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2005-11-23 |
| Summary: | summary |