Cleared Traditional

BOWEN CANNULA

K863150 · Bowen & Company, Inc. · General & Plastic Surgery
Sep 1986
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K863150 is an FDA 510(k) clearance for the BOWEN CANNULA, a Cannula, Surgical, General & Plastic Surgery (Class I — General Controls, product code GEA), submitted by Bowen & Company, Inc. (Rockville, US). The FDA issued a Cleared decision on September 5, 1986, 21 days after receiving the submission on August 15, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K863150 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1986
Decision Date September 05, 1986
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GEA — Cannula, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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