FDA 510(k) Application Details - K011401

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K011401
Device Name Vehicle, Motorized 3-Wheeled
Applicant RAMBLER MOBILITY, INC.
1401 OLD ELKTON DR.
FOREST, VA 24551 US
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Contact JOEL HUSTED
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 05/07/2001
Decision Date 07/13/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K011401


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