Submission Details
| 510(k) Number | K811995 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 13, 1981 |
| Decision Date | September 21, 1981 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
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 review panel.
| 510(k) Number | K811995 FDA.gov |
| FDA Decision | Cleared 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 | — |