Cleared Traditional

MED-TEC HAND GRIP

K954225 · Medtec, Inc. · Radiology
Nov 1995
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K954225 is an FDA 510(k) clearance for the MED-TEC HAND GRIP, a Table, Radiographic, Stationary Top (Class II — Special Controls, product code IXQ), submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on November 14, 1995, 64 days after receiving the submission on September 11, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K954225 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 1995
Decision Date November 14, 1995
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IXQ — Table, Radiographic, Stationary Top
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980

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