510(k) K883619
K883619 is an FDA 510(k) premarket notification submitted by Minnetonka, Inc. for the device "MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL". The FDA issued a decision of SN on September 1, 1989. The device falls under product code SEK (Wound Dressings With Hydrocortisone), a Class U device. Minnetonka, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- September 1, 1989
- Date Received
- August 24, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressings With Hydrocortisone
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
A wound dressing containing hydrocortisone is used to maintain appropriate moisture balance within the wound