The following data is part of a premarket notification filed by Pathway Products, Inc. with the FDA for Amdent Model 830 Ultrasonic Scaler.
| Device ID | K880940 |
| 510k Number | K880940 |
| Device Name: | AMDENT MODEL 830 ULTRASONIC SCALER |
| Classification | Scaler, Ultrasonic |
| Applicant | PATHWAY PRODUCTS, INC. 6800 WESTGATE 139B-148 Austin, TX 78745 |
| Contact | Lee W Palmer |
| Correspondent | Lee W Palmer PATHWAY PRODUCTS, INC. 6800 WESTGATE 139B-148 Austin, TX 78745 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-07 |
| Decision Date | 1988-07-15 |