The following data is part of a premarket notification filed by Giltech Plus, Inc. with the FDA for Giltech Plus Hydrogel Skin Dressing.
| Device ID | K992094 |
| 510k Number | K992094 |
| Device Name: | GILTECH PLUS HYDROGEL SKIN DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | GILTECH PLUS, INC. P.O. BOX 728 Milford, PA 18337 |
| Contact | William J Giliam |
| Correspondent | William J Giliam GILTECH PLUS, INC. P.O. BOX 728 Milford, PA 18337 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-21 |
| Decision Date | 1999-09-17 |