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FDA 510(k) Application Details - K210920
Device Classification Name
Wheelchair, Stair Climbing
More FDA Info for this Device
510(K) Number
K210920
Device Name
Wheelchair, Stair Climbing
Applicant
Mobius Mobility
540 Commercial St. Suite 310
Manchester, NH 03101 US
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Contact
Joseph Sullivan
Other 510(k) Applications for this Contact
Regulation Number
890.3890
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Classification Product Code
IMK
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More FDA Info for this Product Code
Date Received
03/29/2021
Decision Date
06/16/2021
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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