FDA 510(k) Application Details - K091871

Device Classification Name Compressor, Air, Portable

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510(K) Number K091871
Device Name Compressor, Air, Portable
Applicant EKOM S.R.O.
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL 34134 US
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Contact PAUL DRYDEN
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Regulation Number 868.6250

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Classification Product Code BTI
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Date Received 06/23/2009
Decision Date 10/23/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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