The following data is part of a premarket notification filed by Nortrade Medical, Inc. with the FDA for Burnfree (4x4, 8x8, 16x24) Sterile Burn & Wound Dressing.
| Device ID | K990180 |
| 510k Number | K990180 |
| Device Name: | BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | NORTRADE MEDICAL, INC. 9382 SOUTH 670 WEST Sandy, UT 84070 |
| Contact | Jay W Taylor |
| Correspondent | Jay W Taylor NORTRADE MEDICAL, INC. 9382 SOUTH 670 WEST Sandy, UT 84070 |
| 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 | 1999-01-20 |
| Decision Date | 1999-08-13 |