K770120 is an FDA 510(k) clearance for the MOUTH WASH TRAY. This device is classified as a Depressor, Tongue, Non-surgical (Class I - General Controls, product code FMA).
Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1977, 7 days after receiving the submission on January 21, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6230.
| 510(k) Number | K770120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1977 |
| Decision Date | January 28, 1977 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMA — Depressor, Tongue, Non-surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6230 |