The following data is part of a premarket notification filed by Apoza Enterprise Co. Ltd. with the FDA for Led Turbo-pen.
| Device ID | K041303 |
| 510k Number | K041303 |
| Device Name: | LED TURBO-PEN |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | APOZA ENTERPRISE CO. LTD. 6 F,NO.657, CHUANG CHENG ROAD HSIN-CHUANG CITY Taipei Hsien, TW 242 |
| Contact | Shin Min Teh |
| Correspondent | Shin Min Teh APOZA ENTERPRISE CO. LTD. 6 F,NO.657, CHUANG CHENG ROAD HSIN-CHUANG CITY Taipei Hsien, TW 242 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-17 |
| Decision Date | 2004-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719883751317 | K041303 | 000 |
| 04719883750624 | K041303 | 000 |
| 04719883751515 | K041303 | 000 |
| 04719883751492 | K041303 | 000 |
| 04719883751478 | K041303 | 000 |
| 04719883751454 | K041303 | 000 |
| 04719883751447 | K041303 | 000 |