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FDA 510(k) Application Details - K042535
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K042535
Device Name
Wheelchair, Powered
Applicant
ULRICH ALBER GMBH
VOR DEM WEISSEN STEIN 21
ALBSTADT-TAILFINGEN D-72464 DE
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Contact
RALF LEDDA
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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
09/20/2004
Decision Date
10/05/2004
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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