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FDA 510(k) Application Details - K984367
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K984367
Device Name
Wheelchair, Mechanical
Applicant
ADORNO ROGERS TECHNOLOGY
101 WEST 6TH ST., SUITE 409
AUSTIN, TX 78701-2933 US
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Contact
PAUL GIBB
Other 510(k) Applications for this Contact
Regulation Number
890.3850
More FDA Info for this Regulation Number
Classification Product Code
IOR
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More FDA Info for this Product Code
Date Received
12/07/1998
Decision Date
01/28/1999
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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