FDA 510(k) Application Details - K170533

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

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510(K) Number K170533
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant ZOLL Medical Corporation
269 & 271 Mill Road
Chelmsford, MA 01824-4105 US
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Contact Pooja Dalvi
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 02/23/2017
Decision Date 04/18/2017
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 N
Expedited Review



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