Cleared Traditional

K971580 - UAS ULTRASONIC ASPIRATOR SYSTEM
(FDA 510(k) Clearance)

K971580 · Wells Johnson Co. · General & Plastic Surgery
Dec 1997
Decision
223d
Days
Risk

K971580 is an FDA 510(k) clearance for the UAS ULTRASONIC ASPIRATOR SYSTEM, a Instrument, Ultrasonic Surgical, submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on December 9, 1997, 223 days after receiving the submission on April 30, 1997. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K971580 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 1997
Decision Date December 09, 1997
Days to Decision 223 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

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