FDA 510(k) Application Details - K091474

Device Classification Name Syringe, Piston

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510(K) Number K091474
Device Name Syringe, Piston
Applicant MASTERS HEALTHCARE, LLC.
333 MILFORD RD.
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 05/18/2009
Decision Date 07/09/2009
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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