K801374 is an FDA 510(k) clearance for the PROXIMATE (TMD) TISSUE MEASURING DEVICE. This device is classified as a Tape, Measuring, Rulers And Calipers (Class I - General Controls, product code FTY).
Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 26, 1980, 16 days after receiving the submission on June 10, 1980.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K801374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1980 |
| Decision Date | June 26, 1980 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FTY — Tape, Measuring, Rulers And Calipers |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |