FDA 510(k) Application Details - K955736

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K955736
Device Name Stimulator, Muscle, Powered
Applicant BMR LTD.
14900 SWEITZER LN.
SUITE 200
LAURAL, MD 20707 US
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Contact TOM BOONE
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 12/18/1995
Decision Date 05/22/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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