Cleared Traditional

KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601

K070360 · Kirwan Surgical Products, Inc. · General & Plastic Surgery
Aug 2007
Decision
181d
Days
Risk

About This 510(k) Submission

K070360 is an FDA 510(k) clearance for the KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601, a Instrument, Ultrasonic Surgical, submitted by Kirwan Surgical Products, Inc. (Marshfield, US). The FDA issued a Cleared decision on August 7, 2007, 181 days after receiving the submission on February 7, 2007. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K070360 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2007
Decision Date August 07, 2007
Days to Decision 181 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

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