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FDA 510(k) Application Details - K972147
Device Classification Name
Wheelchair, Powered
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510(K) Number
K972147
Device Name
Wheelchair, Powered
Applicant
DYNAMIC SYSTEMS, INC.
5002 N. ROYAL ATLANTA DR., #P
TUCKER, GA 30084 US
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DAVID R COURT
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Regulation Number
890.3860
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Classification Product Code
ITI
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More FDA Info for this Product Code
Date Received
06/09/1997
Decision Date
08/25/1997
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
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