The following data is part of a premarket notification filed by Tpc Advanced Technology, Inc. with the FDA for Powermax 25, Model Pm25; Powermax 30, Model Pm30.
| Device ID | K051547 |
| 510k Number | K051547 |
| Device Name: | POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 |
| Classification | Scaler, Ultrasonic |
| Applicant | TPC ADVANCED TECHNOLOGY, INC. 17588 E. ROWLAND ST. City Of Industry, CA 91748 |
| Contact | Scott Beckley |
| Correspondent | Scott Beckley TPC ADVANCED TECHNOLOGY, INC. 17588 E. ROWLAND ST. City Of Industry, CA 91748 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-13 |
| Decision Date | 2005-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D861PM250 | K051547 | 000 |
| D861A850LED0 | K051547 | 000 |
| D861A800N0 | K051547 | 000 |
| D861A800LED0 | K051547 | 000 |
| D861A750N0 | K051547 | 000 |
| D861A750LED0 | K051547 | 000 |