Cleared Traditional

ASH-7000

K951228 · U.S. Table, Inc. · Physical Medicine
May 1995
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K951228 is an FDA 510(k) clearance for the ASH-7000, a Equipment, Traction, Powered (Class II — Special Controls, product code ITH), submitted by U.S. Table, Inc. (Glen Allen, US). The FDA issued a Cleared decision on May 17, 1995, 58 days after receiving the submission on March 20, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number K951228 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1995
Decision Date May 17, 1995
Days to Decision 58 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code ITH — Equipment, Traction, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5900

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