The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co., Ltd. with the FDA for Suntouch Dental Dressing.
| Device ID | K173196 |
| 510k Number | K173196 |
| Device Name: | SUNTOUCH Dental Dressing |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou, CN 516005 |
| Contact | Junfeng Zhang |
| Correspondent | Junfeng Zhang Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou, CN 516005 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20686864054683 | K173196 | 000 |
| 20686864055086 | K173196 | 000 |
| 00686864060215 | K173196 | 000 |