The following data is part of a premarket notification filed by Belmont Equipment Corp. with the FDA for New Belmont Model, Mc-5 Dental, Intraoral X-ray.
| Device ID | K861328 |
| 510k Number | K861328 |
| Device Name: | NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY |
| Classification | Unit, X-ray, Intraoral |
| Applicant | BELMONT EQUIPMENT CORP. ONE BELMONT DR. Somerset, NJ 08873 |
| Contact | John M Gardella |
| Correspondent | John M Gardella BELMONT EQUIPMENT CORP. ONE BELMONT DR. Somerset, NJ 08873 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-09 |
| Decision Date | 1986-04-24 |