Product code SEK
- Device name
- Wound Dressings With Hydrocortisone
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A wound dressing containing hydrocortisone is used to maintain appropriate moisture balance within the wound
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K883566 | MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL | Minnetonka, Inc. | 1989-09-01 |
| K883619 | MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL | Minnetonka, Inc. | 1989-09-01 |