FDA 510(k) Application Details - K984457

Device Classification Name Wheelchair, Mechanical

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510(K) Number K984457
Device Name Wheelchair, Mechanical
Applicant SUITER MEDICAL L.L.C.
203 WEST 2ND ST.
MC COOK, NE 69001 US
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Contact JAMES P SUITER
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 12/15/1998
Decision Date 01/19/1999
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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