The following data is part of a premarket notification filed by Medicsense U.s.a. with the FDA for Nsk Precision Apex Locator (pal).
| Device ID | K053235 |
| 510k Number | K053235 |
| Device Name: | NSK PRECISION APEX LOCATOR (PAL) |
| Classification | Locator, Root Apex |
| Applicant | MEDICSENSE U.S.A. 291 Hillside Avenue Somerset, MA 02726 |
| Contact | George Hattub |
| Correspondent | George Hattub MEDICSENSE U.S.A. 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-18 |
| Decision Date | 2006-01-24 |
| Summary: | summary |