FDA 510(k) Application Details - K142535

Device Classification Name Syringe, Piston

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510(K) Number K142535
Device Name Syringe, Piston
Applicant CONMED CORPORATION
11311 CONCEPT BLVD.
LARGO, FL 33773 US
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Contact Dionne Sanders
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 09/09/2014
Decision Date 04/23/2015
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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