FDA 510(k) Application Details - K071108

Device Classification Name Syringe, Piston

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510(K) Number K071108
Device Name Syringe, Piston
Applicant CARDINAL HEALTH, ALARIS PRODUCTS
10221 WATERIDGE CIRCLE
SAN DIEGO, CA 92121-2772 US
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Contact STACY L LEWIS
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 04/19/2007
Decision Date 05/24/2007
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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