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FDA 510(k) Application Details - K191334
Device Classification Name
Wheelchair, Standup
More FDA Info for this Device
510(K) Number
K191334
Device Name
Wheelchair, Standup
Applicant
MATIA Robotics (US) Inc
1929 S 4130 W, Unit A
Salt Lake City, UT 84104 US
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Contact
Necati Hacikadiroglu
Other 510(k) Applications for this Contact
Regulation Number
890.3900
More FDA Info for this Regulation Number
Classification Product Code
IPL
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More FDA Info for this Product Code
Date Received
05/17/2019
Decision Date
05/29/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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