FDA 510(k) Application Details - K041779

Device Classification Name Stopcock, I.V. Set

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510(K) Number K041779
Device Name Stopcock, I.V. Set
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 880.5440

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Classification Product Code FMG
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Date Received 07/01/2004
Decision Date 09/21/2004
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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