The following data is part of a premarket notification filed by Bonart Co. Ltd. with the FDA for Bonart Model Art-im1 Implantor System & Accessories.
| Device ID | K100785 |
| 510k Number | K100785 |
| Device Name: | BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | BONART CO. LTD. 398 S. LEMON CREEK DR. SUITE G Walnut, CA 91789 |
| Contact | Eric L Ong |
| Correspondent | Eric L Ong BONART CO. LTD. 398 S. LEMON CREEK DR. SUITE G Walnut, CA 91789 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-19 |
| Decision Date | 2010-12-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873120345 | K100785 | 000 |