The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Hydrogum.
| Device ID | K974704 |
| 510k Number | K974704 |
| Device Name: | HYDROGUM |
| Classification | Material, Impression |
| Applicant | ZHERMACK S.P.A. 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Contact | Evan Dick |
| Correspondent | Evan Dick ZHERMACK S.P.A. 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-16 |
| Decision Date | 1998-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858466005301 | K974704 | 000 |