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FDA 510(k) Application Details - K000808
Device Classification Name
Stimulator, Muscle, Powered
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510(K) Number
K000808
Device Name
Stimulator, Muscle, Powered
Applicant
RICH-MAR CORP.
15499 EAST 590TH RD.
P.O. BOX 879
INOLA, OK 74036-0879 US
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DAVID RICHARDS
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Regulation Number
890.5850
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Classification Product Code
IPF
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More FDA Info for this Product Code
Date Received
03/13/2000
Decision Date
08/25/2000
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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