FDA 510(k) Application Details - K071418

Device Classification Name Accessories, Pump, Infusion

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510(K) Number K071418
Device Name Accessories, Pump, Infusion
Applicant SOOIL DEVELOPMENT CO., LTD.
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact CYNTHIA NOLTE, PH.D
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Regulation Number 880.5725

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Classification Product Code MRZ
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Date Received 05/22/2007
Decision Date 09/04/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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