The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Foramatron V, Model D680.
| Device ID | K002195 |
| 510k Number | K002195 |
| Device Name: | FORAMATRON V, MODEL D680 |
| Classification | Locator, Root Apex |
| Applicant | PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| Contact | Daniel R Schechter |
| Correspondent | Daniel R Schechter PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735 |
| 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 | 2000-07-20 |
| Decision Date | 2000-08-30 |