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FDA 510(k) Application Details - K110567
Device Classification Name
Vehicle, Motorized 3-Wheeled
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510(K) Number
K110567
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
C.T.M. HOMECARE PRODUCT, INC.
927 THRONE DRIVE
EUGENE, OR 97402 US
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Contact
SHEILA RAMERMAN
Other 510(k) Applications for this Contact
Regulation Number
890.3800
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Classification Product Code
INI
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More FDA Info for this Product Code
Date Received
02/28/2011
Decision Date
04/22/2011
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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