Cleared Traditional

INSTRUMENTS FOR ONE TIME USE - DISPOSABLE

K011514 · Kencap , Ltd. · General & Plastic Surgery
Aug 2001
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K011514 is an FDA 510(k) clearance for the INSTRUMENTS FOR ONE TIME USE - DISPOSABLE, a Kit, Surgical Instrument, Disposable (Class I — General Controls, product code KDD), submitted by Kencap , Ltd. (Ringwood, US). The FDA issued a Cleared decision on August 13, 2001, 88 days after receiving the submission on May 17, 2001. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K011514 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2001
Decision Date August 13, 2001
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code KDD — Kit, Surgical Instrument, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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