FDA 510(k) Application Details - K060781

Device Classification Name Compressor, Air, Portable

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510(K) Number K060781
Device Name Compressor, Air, Portable
Applicant EKOM S.R.O.
32884 DANAPOPLAR
DANA POINT, CA 92629 US
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Contact ESTHER SALTZ
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Regulation Number 868.6250

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Classification Product Code BTI
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Date Received 03/22/2006
Decision Date 10/03/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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