Cleared Traditional

DANEK IRRIGATING BURR (DIB) SET

K890090 · Danek Medical, Inc. · General & Plastic Surgery
Jan 1989
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K890090 is an FDA 510(k) clearance for the DANEK IRRIGATING BURR (DIB) SET, a Bur, Surgical, General & Plastic Surgery (Class I — General Controls, product code GFF), submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on January 24, 1989, 14 days after receiving the submission on January 10, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K890090 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 1989
Decision Date January 24, 1989
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GFF — Bur, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

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