Home / 510(k) Clearances / K883566

510(k) K883566

MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL by Minnetonka, Inc. — Product Code SEK

K883566 is an FDA 510(k) premarket notification submitted by Minnetonka, Inc. for the device "MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE 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 22, 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

Other clearances by Minnetonka, Inc.

  • K883619 — MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL (September 1, 1989)
  • K860843 — CHECK-UP PLAQUE FIGHTING GUM (May 21, 1986)
  • K831488 — DAVRON PROF. SCRUB BRUSH-DRY/STERILE (June 8, 1983)

Other clearances for product code SEK

  • K883619 — MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL (September 1, 1989)

FDA data resources