BURNFREE (4X4, 8X8, 16X24) STERILE BURN & WOUND DRESSING

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

NORTRADE MEDICAL, INC.

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.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00743537000760	K990180	000
00743537000821	K990180	000
00743537000807	K990180	000
00743537000784	K990180	000