FDA 510(k) Application Details - K062865

Device Classification Name Syringe, Piston

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510(K) Number K062865
Device Name Syringe, Piston
Applicant ALCON LABORATORIES
6201 S FREEWAY
FT WORTH, TX 76134 US
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Contact SEAN P GRIFFIN
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 09/25/2006
Decision Date 08/23/2007
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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