The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Hydrogum Soft.
| Device ID | K043118 |
| 510k Number | K043118 |
| Device Name: | HYDROGUM SOFT |
| Classification | Material, Impression |
| Applicant | ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Contact | Gerald W Shipps |
| Correspondent | Gerald W Shipps ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend, OR 97702 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-10 |
| Decision Date | 2005-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205107657 | K043118 | 000 |
| 00883205107640 | K043118 | 000 |
| 48033712560326 | K043118 | 000 |
| 48033712560319 | K043118 | 000 |