The following data is part of a premarket notification filed by Bomei Co., Ltd with the FDA for Obs Anchorage Screw.
| Device ID | K152297 |
| 510k Number | K152297 |
| Device Name: | OBS Anchorage Screw |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | BOMEI CO., LTD 4F., NO.1492-2, CHUNRIH RD., TAOYUAN DIST. Taoyuan City, TW 33051 |
| Contact | Linney Chiang |
| Correspondent | Shaoyin Peng SHAOYIN PENG 258 N BAY DR. Bullard, TX 75757 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-13 |
| Decision Date | 2016-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873180028 | K152297 | 000 |
| 04719873180158 | K152297 | 000 |
| 04719873180165 | K152297 | 000 |
| 04719873180189 | K152297 | 000 |
| 04719873180196 | K152297 | 000 |
| 04719873180202 | K152297 | 000 |
| 04719873180219 | K152297 | 000 |
| 04719873180226 | K152297 | 000 |
| 04719873180233 | K152297 | 000 |
| 04719873180141 | K152297 | 000 |
| 04719873180134 | K152297 | 000 |
| 04719873180127 | K152297 | 000 |
| 04719873180035 | K152297 | 000 |
| 04719873180042 | K152297 | 000 |
| 04719873180059 | K152297 | 000 |
| 04719873180066 | K152297 | 000 |
| 04719873180073 | K152297 | 000 |
| 04719873180080 | K152297 | 000 |
| 04719873180103 | K152297 | 000 |
| 04719873180110 | K152297 | 000 |
| 04719873180240 | K152297 | 000 |
| 04719873180264 | K152297 | 000 |
| 04719873180394 | K152297 | 000 |
| 04719873180400 | K152297 | 000 |
| 04719873180424 | K152297 | 000 |
| 04719873180431 | K152297 | 000 |
| 04719873180448 | K152297 | 000 |
| 04719873180455 | K152297 | 000 |
| 04719873180462 | K152297 | 000 |
| 04719873180479 | K152297 | 000 |
| 04719873180387 | K152297 | 000 |
| 04719873180370 | K152297 | 000 |
| 04719873180363 | K152297 | 000 |
| 04719873180271 | K152297 | 000 |
| 04719873180288 | K152297 | 000 |
| 04719873180295 | K152297 | 000 |
| 04719873180301 | K152297 | 000 |
| 04719873180318 | K152297 | 000 |
| 04719873180325 | K152297 | 000 |
| 04719873180349 | K152297 | 000 |
| 04719873180356 | K152297 | 000 |
| 04719873180585 | K152297 | 000 |