The following data is part of a premarket notification filed by Belmont Equipment Corp. with the FDA for Belmont Unit, Model 6000 Series And 7500 Series.
| Device ID | K983661 |
| 510k Number | K983661 |
| Device Name: | BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES |
| Classification | Unit, Operative Dental |
| Applicant | BELMONT EQUIPMENT CORP. 101 BELMONT DR. Somerset, NJ 08873 -1204 |
| Contact | John E Collins |
| Correspondent | John E Collins BELMONT EQUIPMENT CORP. 101 BELMONT DR. Somerset, NJ 08873 -1204 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-19 |
| Decision Date | 1999-01-12 |