Cleared Traditional

K863931 - CARBONET ODOUR ADSORBING DRESSING (FDA 510(k) Clearance)

Dec 1986
Decision
54d
Days
Risk

K863931 is an FDA 510(k) clearance for the CARBONET ODOUR ADSORBING DRESSING..

Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on December 1, 1986, 54 days after receiving the submission on October 8, 1986.

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

Submission Details

510(k) Number K863931 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 08, 1986
Decision Date December 01, 1986
Days to Decision 54 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class