FDA 510(k) Application Details - K022246

Device Classification Name Syringe, Piston

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510(K) Number K022246
Device Name Syringe, Piston
Applicant DEPUY ACROMED
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
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Contact KAREN F JURCZAK
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 07/12/2002
Decision Date 08/02/2002
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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