K811995 is an FDA 510(k) clearance for the FORAMATRON APICAL FORAMEN LOCATOR..
Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1981, 70 days after receiving the submission on July 13, 1981.
This device falls under the Dental FDA review panel.
| 510(k) Number | K811995 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1981 |
| Decision Date | September 21, 1981 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | — |
| Device Class | — |