Cleared Traditional

MEDICAL DYNAMICS LIGHT SOURCE

K894319 · Medical Dynamics, Inc. · General & Plastic Surgery
Oct 1989
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K894319 is an FDA 510(k) clearance for the MEDICAL DYNAMICS LIGHT SOURCE, a Light, Surgical, Endoscopic (Class II — Special Controls, product code FSW), submitted by Medical Dynamics, Inc. (Englewood, US). The FDA issued a Cleared decision on October 3, 1989, 81 days after receiving the submission on July 14, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K894319 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1989
Decision Date October 03, 1989
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FSW — Light, Surgical, Endoscopic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

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