FDA 510(k) Application Details - K081185

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

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510(K) Number K081185
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant OHIO MEDICAL CORPORATION
1111 LAKESIDE DR.
GURNEE, IL 60031 US
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Contact DAVID PLATT
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 04/25/2008
Decision Date 05/02/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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