The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Hg Ii Fixture System.
| Device ID | K090237 |
| 510k Number | K090237 |
| Device Name: | HG II FIXTURE SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | HIOSSEN INC. 85 BEN FAIRLESS DRIVE Fairless Hills, PA 19030 |
| Contact | Minjoo Kim |
| Correspondent | Minjoo Kim HIOSSEN INC. 85 BEN FAIRLESS DRIVE Fairless Hills, PA 19030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-02 |
| Decision Date | 2009-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814913021416 | K090237 | 000 |
| 00814913021287 | K090237 | 000 |
| 00814913021270 | K090237 | 000 |
| 00814913021263 | K090237 | 000 |
| 00814913021256 | K090237 | 000 |
| 00814913021249 | K090237 | 000 |
| 00814913021232 | K090237 | 000 |
| 00814913021225 | K090237 | 000 |
| 00814913021218 | K090237 | 000 |
| 00814913021201 | K090237 | 000 |
| 00814913021294 | K090237 | 000 |
| 00814913021300 | K090237 | 000 |
| 00814913021317 | K090237 | 000 |
| 00814913021409 | K090237 | 000 |
| 00814913021393 | K090237 | 000 |
| 00814913021386 | K090237 | 000 |
| 00814913021379 | K090237 | 000 |
| 00814913021362 | K090237 | 000 |
| 00814913021355 | K090237 | 000 |
| 00814913021348 | K090237 | 000 |
| 00814913021331 | K090237 | 000 |
| 00814913021324 | K090237 | 000 |
| 00814913021195 | K090237 | 000 |