FDA 510(k) Application Details - K061183

Device Classification Name Syringe, Piston

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510(K) Number K061183
Device Name Syringe, Piston
Applicant CONFLUENT SURGICAL,INC
101A FIRST AVE.
WALTHAM, MA 02451 US
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Contact ERIC P ANKERUD
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 04/28/2006
Decision Date 06/01/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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