Cleared Traditional

K883588 - COMPEED ATHLETIC DRESSING (FDA 510(k) Clearance)

Sep 1988
Decision
31d
Days
Risk

K883588 is an FDA 510(k) clearance for the COMPEED ATHLETIC DRESSING. This device is classified as a Dressing, Wound, Drug.

Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on September 22, 1988, 31 days after receiving the submission on August 22, 1988.

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

Submission Details

510(k) Number K883588 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 22, 1988
Decision Date September 22, 1988
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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