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510(k) K883619

MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL by Minnetonka, Inc. — Product Code SEK

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