FDA 510(k) Application Details - K070917

Device Classification Name Syringe, Piston

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510(K) Number K070917
Device Name Syringe, Piston
Applicant FEEL TECH
P.O. BOX 7007
DEERFIELD, IL 60015 US
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Contact DANIEL KAMM
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 04/02/2007
Decision Date 06/20/2007
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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