Dressing, Wound And Burn, Occlusive, Heated
A Heated Occlusive Wound and Burn Dressing is a wound care device that provides a sealed, moisture-retentive covering combined with thermal warming properties, intended to promote healing of wounds and burns. It is classified as FDA Class 1, subject to general controls but not exempt from GMP requirements, meaning it must comply with standard quality system regulations without needing a premarket submission. The product code is MSA, regulated under 21 CFR 878.4020 in the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MSA
- Device Class
- FDA class 1
- Regulation Number
- 878.4020
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K020077 | MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX | Jan 31, 2002 | Substantially Equivalent | Augustine Medical, Inc. |
| K963293 | AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX | Mar 28, 1997 | Substantially Equivalent for Some Indications | Augustine Medical, Inc. |