The following data is part of a premarket notification filed by Hiossen, Inc. with the FDA for Em Provisional.
| Device ID | K191751 |
| 510k Number | K191751 |
| Device Name: | EM Provisional |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Hiossen, Inc. 85 Ben Fairless Drive Fairless Hills, PA 19030 |
| Contact | Peter Lee |
| Correspondent | Peter Lee Hiossen, Inc. 85 Ben Fairless Drive Fairless Hills, PA 19030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-01 |
| Decision Date | 2019-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810019243639 | K191751 | 000 |
| 00810019243622 | K191751 | 000 |
| 00810019243615 | K191751 | 000 |
| 00810019243608 | K191751 | 000 |
| 00810019243592 | K191751 | 000 |
| 00810019243585 | K191751 | 000 |