FDA 510(k) Application Details - K984021

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K984021
Device Name Stimulator, Muscle, Powered
Applicant LSI INTL., INC.
8849 BOND
OVERLAND PARK, KS 66214 US
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Contact JAMES C LANE
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 11/12/1998
Decision Date 01/28/1999
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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