FDA 510(k) Application Details - K081053

Device Classification Name Chair, Positioning, Electric

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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
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Regulation Number 890.3110

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Classification Product Code INO
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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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