FDA 510(k) Application Details - K040239

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

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510(K) Number K040239
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant NEOMEDIX CORP.
27452 CALLE ARROYO
SAN JUAN CAPISTRANO, CA 92675-2748 US
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Contact SOHEILA MIRHASHEMI
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 02/02/2004
Decision Date 02/17/2004
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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