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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K073701
Device Name DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000
Applicant
Dane Technologies
7105 Northland Terrace
Brooklyn Park,  MN  55428
Applicant Contact OLIVER PITTENGER
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/31/2007
Decision Date 01/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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