FDA 510(k) Application Details - K103042

Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)

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510(K) Number K103042
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant ATMOS INC.
3717 HUCKLEBERRY ROAD
ALLENTOWN, PA 18104 US
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Contact MARCO SCHLEGEL
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 10/14/2010
Decision Date 04/15/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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