FDA 510(k) Application Details - K062801

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

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510(K) Number K062801
Device Name Pump, Portable, Aspiration (Manual Or Powered)
Applicant HAEMONETICS CORP.
400 WOOD ROAD
BRAINTREE, MA 02184-9114 US
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Contact GABRIEL J MURACA
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Regulation Number 878.4780

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Classification Product Code BTA
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Date Received 09/19/2006
Decision Date 10/04/2006
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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