FDA 510(k) Application Details - K030683

Device Classification Name Syringe, Piston

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510(K) Number K030683
Device Name Syringe, Piston
Applicant NIPRO MEDICAL CORP.
1384 COPPERFIELD COURT
LEXINGTON, KY 40514-1268 US
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Contact KAELYN B HADLEY
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 03/05/2003
Decision Date 10/31/2003
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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