The following data is part of a premarket notification filed by Dumex Medical Surgical Products, Ltd. with the FDA for Sterile Hydrogel.
| Device ID | K993119 |
| 510k Number | K993119 |
| Device Name: | STERILE HYDROGEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
| Contact | Sam Lakhani |
| Correspondent | Sam Lakhani DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
| 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 | 1999-09-20 |
| Decision Date | 1999-11-23 |