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FDA 510(k) Application Details - K083017
Device Classification Name
Wheelchair, Standup
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510(K) Number
K083017
Device Name
Wheelchair, Standup
Applicant
LEVO AG
ANGLIKERSTRASSE 20
5610 WOHLEN CH-5610 CH
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Contact
THOMAS RABER
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Regulation Number
890.3900
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Classification Product Code
IPL
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Date Received
10/09/2008
Decision Date
10/24/2008
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
Y
Expedited Review
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