The following data is part of a premarket notification filed by Medicnrg Ltd. with the FDA for Apex Dal Electronic Apex Locator.
| Device ID | K080113 |
| 510k Number | K080113 |
| Device Name: | APEX DAL ELECTRONIC APEX LOCATOR |
| Classification | Locator, Root Apex |
| Applicant | MEDICNRG LTD. 291 HILLSIDE AVE. Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub MEDICNRG LTD. 291 HILLSIDE AVE. Somerset, MA 02726 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-16 |
| Decision Date | 2008-02-15 |
| Summary: | summary |