FDA 510(k) Application Details - K040622

Device Classification Name Wheelchair, Mechanical

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510(K) Number K040622
Device Name Wheelchair, Mechanical
Applicant FREEDOM DESIGNS, INC.
2241 MADERA RD.
SIMI VALLEY, CA 93065 US
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Contact GINNY S MALOCO
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 03/09/2004
Decision Date 04/16/2004
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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