Cleared Traditional

TRACTION TABLE MODEL #825-200

K930259 · Biodan Medical Systems, Ltd. · Physical Medicine
Mar 1993
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K930259 is an FDA 510(k) clearance for the TRACTION TABLE MODEL #825-200, a Table, Physical Therapy, Multi Function (Class II — Special Controls, product code JFB), submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on March 24, 1993, 64 days after receiving the submission on January 19, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number K930259 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1993
Decision Date March 24, 1993
Days to Decision 64 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code JFB — Table, Physical Therapy, Multi Function
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5880

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