FDA 510(k) Application Details - K002717

Device Classification Name Syringe, Piston

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510(K) Number K002717
Device Name Syringe, Piston
Applicant ABBOTT LABORATORIES
D-389, AP-30
200 ABBOTT PARK ROAD
ABBOTT PARK, IL 60064-3537 US
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Contact THOMAS P SAMPONGA
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 08/31/2000
Decision Date 01/08/2001
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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