Cleared Traditional

KOMET XK-95 PERFORATOR MOTOR (MI-102)

K991625 · Komet Medical · Neurology
Jul 1999
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K991625 is an FDA 510(k) clearance for the KOMET XK-95 PERFORATOR MOTOR (MI-102), a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by Komet Medical (Savannah, US). The FDA issued a Cleared decision on July 30, 1999, 80 days after receiving the submission on May 11, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K991625 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1999
Decision Date July 30, 1999
Days to Decision 80 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code HBB — Motor, Drill, Pneumatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4370

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