FDA 510(k) Application Details - K061092

Device Classification Name Syringe, Piston

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510(K) Number K061092
Device Name Syringe, Piston
Applicant MICROMEDICS, INC.
1270 EAGAN INDUSTRIAL ROAD
SUITE 120
EAGAN, MN 55121 US
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Contact THOMAS LOPAC
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 04/19/2006
Decision Date 09/13/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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