FDA 510(k) Application Details - K071732

Device Classification Name Needle, Aspiration And Injection, Reusable

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510(K) Number K071732
Device Name Needle, Aspiration And Injection, Reusable
Applicant STEMCOR SYSTEMS, INC.
5582 CHALON ROAD
YORBA LINDA, CA 92886 US
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Contact SHARON ROCKWELL
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Regulation Number 878.4800

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Classification Product Code GDM
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Date Received 06/26/2007
Decision Date 09/24/2007
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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