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FDA 510(k) Application Details - K982989
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K982989
Device Name
Wheelchair, Mechanical
Applicant
SUNRISE MEDICAL, INC.
7477 EAST DRY CREEK PKWY.
LONGMONT, CO 80503 US
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Contact
REBECCA ANDERSEN
Other 510(k) Applications for this Contact
Regulation Number
890.3850
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Classification Product Code
IOR
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More FDA Info for this Product Code
Date Received
08/26/1998
Decision Date
10/05/1998
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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