Cleared Traditional

K943424 - CUSH ISLAND DRESSING
(FDA 510(k) Clearance)

K943424 · Cush Medical Products · General & Plastic Surgery
Oct 1994
Decision
80d
Days
Risk

K943424 is an FDA 510(k) clearance for the CUSH ISLAND DRESSING. This device is classified as a Dressing, Wound And Burn, Occlusive.

Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on October 3, 1994, 80 days after receiving the submission on July 15, 1994.

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

Submission Details

510(k) Number K943424 FDA.gov
FDA Decision Cleared SN
Date Received July 15, 1994
Decision Date October 03, 1994
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code MGP — Dressing, Wound And Burn, Occlusive
Device Class

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