FDA 510(k) Application Details - K090130

Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump

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510(K) Number K090130
Device Name Negative Pressure Wound Therapy Powered Suction Pump
Applicant ATMOS INC.
1600 MANCHESTER WAY
CORINTH, TX 76210 US
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Contact CARL ALLETTO
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Regulation Number 878.4780

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Classification Product Code OMP
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Date Received 01/21/2009
Decision Date 04/02/2009
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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