The following data is part of a premarket notification filed by Hedonist Biochemical Technologies Co., Ltd. with the FDA for Suile Ointment Wound Dressing.
| Device ID | K041013 |
| 510k Number | K041013 |
| Device Name: | SUILE OINTMENT WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. 6F, NO. 208, RUEI-GUANG ROAD Taipei, TW 114 |
| Contact | Eric Luo, Ph.d. |
| Correspondent | Eric Luo, Ph.d. HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD. 6F, NO. 208, RUEI-GUANG ROAD Taipei, TW 114 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-04-20 |
| Decision Date | 2004-07-07 |