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510(k) K010292

DRX 2000 by Axiom Worldwide, Inc. — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2001
Date Received
January 31, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type

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