FDA 510(k) Application Details - K101614

Device Classification Name Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

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510(K) Number K101614
Device Name Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Applicant DM SYSTEMS, INCORPORATED
1105 BUCHBRUSH DR
FOLSM, CA 95630 US
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Contact MICHAEL ZMUDA
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Regulation Number 880.5780

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Classification Product Code DWL
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Date Received 06/09/2010
Decision Date 01/13/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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