The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Modification To: Hg Iii Ultra Wide System.
| Device ID | K093889 |
| 510k Number | K093889 |
| Device Name: | MODIFICATION TO: HG III ULTRA WIDE SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | HIOSSEN INC. 85 BEN FAIRLESS DRIVE Fairless Hills, PA 19030 |
| Contact | Patrick Lim |
| Correspondent | Patrick Lim HIOSSEN INC. 85 BEN FAIRLESS DRIVE Fairless Hills, PA 19030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-18 |
| Decision Date | 2010-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814913022178 | K093889 | 000 |
| 00814913022093 | K093889 | 000 |
| 00814913022109 | K093889 | 000 |
| 00814913022116 | K093889 | 000 |
| 00814913022123 | K093889 | 000 |
| 00814913022130 | K093889 | 000 |
| 00814913022147 | K093889 | 000 |
| 00814913022154 | K093889 | 000 |
| 00814913022161 | K093889 | 000 |
| 00814913022086 | K093889 | 000 |