FDA 510(k) Application Details - K022523

Device Classification Name Set, I.V. Fluid Transfer

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510(K) Number K022523
Device Name Set, I.V. Fluid Transfer
Applicant BAXA CORP.
13760 EAST ARAPAHOE RD.
ENGLEWOOD, CO 80112-3903 US
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Contact KARL STEINBECK
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Regulation Number 880.5440

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Classification Product Code LHI
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Date Received 07/30/2002
Decision Date 08/12/2002
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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