FDA 510(k) Application Details - K061632

Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning

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510(K) Number K061632
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant DOMINO S.R.L.
18 EUSTACE DRIVE
WEST HARTFORD, CT 06110 US
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Contact GIOVANNI CIRIANI
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 06/12/2006
Decision Date 04/30/2007
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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