FDA 510(k) Application Details - K990157

Device Classification Name Wheelchair, Mechanical

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510(K) Number K990157
Device Name Wheelchair, Mechanical
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 890.3850

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Classification Product Code IOR
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Date Received 01/19/1999
Decision Date 02/03/1999
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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