FMA — Depressor, Tongue, Non-Surgical Class I
FDA product code FMA covers "Depressor, Tongue, Non-Surgical", a Class I medical device regulated under 21 CFR 880.6230. Submissions are reviewed by the General Hospital panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FMA
- Device Class
- Class I
- Regulation Number
- 880.6230
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K992995 | aga plastic ind. com. ltda | AROMATIC AND FLAVORED TONGUE DEPRESSOR | December 9, 1999 |
| K842461 | torrent | TONGUE DEPRESSOR | November 30, 1984 |
| K830705 | pharmaquest | MINI LANCET-BLOOD LANCET | April 8, 1983 |
| K821177 | abco dealers | BITE STICK | May 21, 1982 |
| K770120 | pharmaseal div., baxter healthcare | MOUTH WASH TRAY | January 28, 1977 |