The following data is part of a premarket notification filed by Tpc Advanced Technology, Inc. with the FDA for Power Plus 25k Model, S1000, Power Plus 30k Model,s1001.
| Device ID | K983029 |
| 510k Number | K983029 |
| Device Name: | POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001 |
| Classification | Scaler, Ultrasonic |
| Applicant | TPC ADVANCED TECHNOLOGY, INC. 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Contact | Carol Patterson |
| Correspondent | Carol Patterson TPC ADVANCED TECHNOLOGY, INC. 18140 SMOKESIGNAL DR. San Diego, CA 92127 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-31 |
| Decision Date | 1999-01-29 |
| Summary: | summary |