The following data is part of a premarket notification filed by Apoza Enterprise Co. Ltd. with the FDA for Apoza Ultrasonic Scaler And Edodontics Unit, Selector U2.
| Device ID | K033198 |
| 510k Number | K033198 |
| Device Name: | APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 |
| Classification | Scaler, Ultrasonic |
| Applicant | APOZA ENTERPRISE CO. LTD. 6 F,NO.657, CHUANG CHENG ROAD HSIN-CHUANG CITY Taipei Hsien, TW 242 |
| Contact | Shih Min-teh |
| Correspondent | Shih Min-teh APOZA ENTERPRISE CO. LTD. 6 F,NO.657, CHUANG CHENG ROAD HSIN-CHUANG CITY Taipei Hsien, TW 242 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-02 |
| Decision Date | 2004-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719883751102 | K033198 | 000 |
| 04719883751416 | K033198 | 000 |
| 04719883751409 | K033198 | 000 |
| 04719883751393 | K033198 | 000 |
| 04719883751386 | K033198 | 000 |