The following data is part of a premarket notification filed by Bonart Co. Ltd. with the FDA for Bonart's Arteotomy Omi And Opi Ultrasonic Surgery System & Accessories.
| Device ID | K080761 |
| 510k Number | K080761 |
| Device Name: | BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES |
| Classification | Drill, Bone, Powered |
| Applicant | BONART CO. LTD. 398 S. LEMON CREEK DR. STE. L Walnut, CA 91789 |
| Contact | Eric L Ong |
| Correspondent | Eric L Ong BONART CO. LTD. 398 S. LEMON CREEK DR. STE. L Walnut, CA 91789 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-18 |
| Decision Date | 2008-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873121199 | K080761 | 000 |
| 04719873120413 | K080761 | 000 |
| 04719873120406 | K080761 | 000 |
| 04719873120390 | K080761 | 000 |
| 04719873120383 | K080761 | 000 |
| 04719873120352 | K080761 | 000 |
| 04719873120338 | K080761 | 000 |
| 04719873120321 | K080761 | 000 |
| 04719873120307 | K080761 | 000 |
| 04719873120284 | K080761 | 000 |
| 04719873120260 | K080761 | 000 |
| 04719873120253 | K080761 | 000 |
| 04719873120246 | K080761 | 000 |
| 04719873120017 | K080761 | 000 |
| 04719873121274 | K080761 | 000 |
| 04719873120420 | K080761 | 000 |
| 04719873120437 | K080761 | 000 |
| 04719873121175 | K080761 | 000 |
| 04719873121168 | K080761 | 000 |
| 04719873121106 | K080761 | 000 |
| 04719873121069 | K080761 | 000 |
| 04719873121007 | K080761 | 000 |
| 04719873120994 | K080761 | 000 |
| 04719873120987 | K080761 | 000 |
| 04719873120901 | K080761 | 000 |
| 04719873120895 | K080761 | 000 |
| 04719873120888 | K080761 | 000 |
| 04719873120833 | K080761 | 000 |
| 04719873120826 | K080761 | 000 |
| 04719873120451 | K080761 | 000 |
| 04719873120444 | K080761 | 000 |
| 04719873121359 | K080761 | 000 |