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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 K042535
Device Name ADVENTURE A10
Applicant
Ulrich Alber GmbH
Vor Dem Weissen Stein 21
Albstadt-Tailfingen,  DE D-72464
Applicant Contact RALF LEDDA
Correspondent
Tuv America, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/20/2004
Decision Date 10/05/2004
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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