Cleared Traditional

MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.

K896019 · Dlp, Inc. · General & Plastic Surgery
Jan 1990
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K896019 is an FDA 510(k) clearance for the MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI., a Needle, Aspiration And Injection, Disposable (Class I — General Controls, product code GAA), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on January 3, 1990, 79 days after receiving the submission on October 16, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K896019 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1989
Decision Date January 03, 1990
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GAA — Needle, Aspiration And Injection, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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