The following data is part of a premarket notification filed by American Medical & Dental Corp. with the FDA for Neosono 2000.
| Device ID | K955088 |
| 510k Number | K955088 |
| Device Name: | NEOSONO 2000 |
| Classification | Locator, Root Apex |
| Applicant | AMERICAN MEDICAL & DENTAL CORP. 1236 BRACE RD. BUILDING B Cherry Hill, NJ 08034 |
| Contact | Jerome Farber |
| Correspondent | Jerome Farber AMERICAN MEDICAL & DENTAL CORP. 1236 BRACE RD. BUILDING B Cherry Hill, NJ 08034 |
| 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 | 1995-11-07 |
| Decision Date | 1996-07-10 |