K893415 is an FDA 510(k) clearance for the TRANS-ORAL DEPTH GAUGE. This device is classified as a Accessories, Fixation, Spinal Intervertebral Body (Class I - General Controls, product code LYQ).
Submitted by Ruggles Corp. (No. Quincy, US). The FDA issued a Cleared decision on June 7, 1989, 36 days after receiving the submission on May 2, 1989.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K893415 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1989 |
| Decision Date | June 07, 1989 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LYQ — Accessories, Fixation, Spinal Intervertebral Body |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |