Cleared Traditional

AUTOGEL PAD

K031018 · Rich-Mar Corp. · Radiology
Dec 2003
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K031018 is an FDA 510(k) clearance for the AUTOGEL PAD, a Media, Coupling, Ultrasound (Class II — Special Controls, product code MUI), submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on December 8, 2003, 252 days after receiving the submission on March 31, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K031018 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2003
Decision Date December 08, 2003
Days to Decision 252 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code MUI — Media, Coupling, Ultrasound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1570

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