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FDA 510(k) Application Details - K981422
Device Classification Name
Wheelchair, Mechanical
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510(K) Number
K981422
Device Name
Wheelchair, Mechanical
Applicant
GET A LIFE-GIVE A LIVING PLUS KIDS PROJECT, INC.
6561 44TH ST. N.
PINELLAS PARK, FL 33781 US
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EUGENE M NAVES
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Regulation Number
890.3850
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Classification Product Code
IOR
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Date Received
04/20/1998
Decision Date
06/10/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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