Cleared Traditional

WILTEK IRRIGAITON/ASPIRATION TUBE SET

K922989 · Wiltek Medical, Inc. · General Hospital
Feb 1994
Decision
603d
Days
Class 2
Risk

About This 510(k) Submission

K922989 is an FDA 510(k) clearance for the WILTEK IRRIGAITON/ASPIRATION TUBE SET, a Tube, Aspirating, Flexible, Connecting (Class II — Special Controls, product code BYY), submitted by Wiltek Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on February 15, 1994, 603 days after receiving the submission on June 22, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K922989 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1992
Decision Date February 15, 1994
Days to Decision 603 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code BYY — Tube, Aspirating, Flexible, Connecting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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