Cleared Traditional

K952775 - DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING (FDA 510(k) Clearance)

Oct 1995
Decision
112d
Days
Risk

K952775 is an FDA 510(k) clearance for the DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING. This device is classified as a Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on October 6, 1995, 112 days after receiving the submission on June 16, 1995.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K952775 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 16, 1995
Decision Date October 06, 1995
Days to Decision 112 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code MGQ — Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class