The following data is part of a premarket notification filed by Somnics Inc. with the FDA for Hypnospad.
| Device ID | K152660 |
| 510k Number | K152660 |
| Device Name: | HYPNOSPAD |
| Classification | Device, Anti-snoring |
| Applicant | Somnics Inc. 5F , No.22, Sec. 2, Sheng Yi Road., Hsinchu Science Park Zhubei City Hsinchu County, TW 30261 |
| Contact | Tsung-min Hsieh |
| Correspondent | Tsung-min Hsieh Somnics Inc. 5F , No.22, Sec. 2, Sheng Yi Road., Hsinchu Science Park Zhubei City Hsinchu County, TW 30261 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-17 |
| Decision Date | 2016-11-09 |
| Summary: | summary |