FDA 510(k) Application Details - K071284

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K071284
Device Name Vehicle, Motorized 3-Wheeled
Applicant DALTON MEDICAL CORP.
1103 VENTURE CT.
CARROLLTON, TX 75006 US
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Contact WILL RIDGWAY
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 05/07/2007
Decision Date 07/26/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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