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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K873500
Device Name MINI CROSSER BATTERY POWERED WHEELCHAIR
Applicant
Heisteel DK Aps
1293 Meadow Trace
Marietta,  GA  30066
Applicant Contact ROBERT MORSCH
Correspondent
Heisteel DK Aps
1293 Meadow Trace
Marietta,  GA  30066
Correspondent Contact ROBERT MORSCH
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/31/1987
Decision Date 01/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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