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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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More FDA Info for this Product Code
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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