Cleared Traditional

JMS HALO APPLICATION TRAY

K864969 · Jerome Medical · General & Plastic Surgery
Feb 1987
Decision
58d
Days
Class 1
Risk

About This 510(k) Submission

K864969 is an FDA 510(k) clearance for the JMS HALO APPLICATION TRAY, a Kit, Surgical Instrument, Disposable (Class I — General Controls, product code KDD), submitted by Jerome Medical (Mt Laurel, US). The FDA issued a Cleared decision on February 18, 1987, 58 days after receiving the submission on December 22, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K864969 FDA.gov
FDA Decision Cleared SESD
Date Received December 22, 1986
Decision Date February 18, 1987
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

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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