Cleared Traditional

K901974 - SELECTOR ULTRASONIC SURGICAL ASPIRATOR (FDA 510(k) Clearance)

Sep 1990
Decision
127d
Days
Risk

K901974 is an FDA 510(k) clearance for the SELECTOR ULTRASONIC SURGICAL ASPIRATOR. This device is classified as a Instrument, Ultrasonic Surgical.

Submitted by Spembly Medical , Ltd. (England, GB). The FDA issued a Cleared decision on September 5, 1990, 127 days after receiving the submission on May 1, 1990.

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

Submission Details

510(k) Number K901974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1990
Decision Date September 05, 1990
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

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