Cleared Traditional

PLASTIC SUCTION TIPS

K832521 · Wells Johnson Co. · General & Plastic Surgery
Oct 1983
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K832521 is an FDA 510(k) clearance for the PLASTIC SUCTION TIPS, a Cannula, Surgical, General & Plastic Surgery (Class I — General Controls, product code GEA), submitted by Wells Johnson Co. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1983, 73 days after receiving the submission on August 8, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K832521 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 1983
Decision Date October 20, 1983
Days to Decision 73 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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