The following data is part of a premarket notification filed by Drtech Corp. with the FDA for Flaatz 760.
| Device ID | K111655 |
| 510k Number | K111655 |
| Device Name: | FLAATZ 760 |
| Classification | System, X-ray, Stationary |
| Applicant | DRTECH CORP. 333-1, SANGDEAWON 1-DONG JUNGWON-GU Seongnam-shi, Gyeonggi-do, KR 462-807 |
| Contact | Choul-woo Shin |
| Correspondent | Choul-woo Shin DRTECH CORP. 333-1, SANGDEAWON 1-DONG JUNGWON-GU Seongnam-shi, Gyeonggi-do, KR 462-807 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-13 |
| Decision Date | 2011-11-30 |
| Summary: | summary |