Data / Medical devices / United States / Hedonist Biochemical Technologies (usa), Inc.
Hedonist Biochemical Technologies (usa), Inc.: FDA-registered device maker in Plano, TX, United States, 2 510(k) clearances
Hedonist Biochemical Technologies (usa), Inc. is registered with the FDA (registration 3004727227) in Plano, TX, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 7, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004727227
- Address
- 101 East Park Boulevard, Suite #600, Plano, TX, United States, 75074
- Owner or operator
- Hedonist Biochemical Technologies (USA), Inc. (9067996)
- Roles
- Specification developer
- First device listed
- December 26, 2007
- Registered through
- 2026
- Brand names listed
- Suile Ointment Wound Dressing, Suile Wound Dressing
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 7, 2004 | K041013 | SUILE OINTMENT WOUND DRESSING | FRO | Substantially Equivalent | Hedonist Biochemical Technologies Co., Ltd. | accessdata.fda.gov |
| July 8, 2003 | K022967 | SUILE WOUND DRESSING | FRO | Substantially Equivalent | Hedonist Biochemical Technologies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 7, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.