FDA 510(k) Application Details - K992052

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K992052
Device Name Vehicle, Motorized 3-Wheeled
Applicant INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA, OH 44036 US
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Contact EDWARD A KROLL
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 06/18/1999
Decision Date 08/12/1999
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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