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FDA 510(k) Application Details - K081053
Device Classification Name
Chair, Positioning, Electric
More FDA Info for this Device
510(K) Number
K081053
Device Name
Chair, Positioning, Electric
Applicant
PIVOT ASSIST, LLC
9335 MCCRACKEN BLVD.
GARFIELD HTS., OH 44125 US
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Contact
JOHN QUIGLEY
Other 510(k) Applications for this Contact
Regulation Number
890.3110
More FDA Info for this Regulation Number
Classification Product Code
INO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/14/2008
Decision Date
10/09/2008
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
FDA Source Information for K081053
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