FDA 510(k) Application Details - K071269

Device Classification Name Arterial Blood Sampling Kit

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510(K) Number K071269
Device Name Arterial Blood Sampling Kit
Applicant SMITHS MEDICAL ASD, INC.
6250 SHIER RINGS RD.
DUBLIN, OH 40316 US
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Contact BARBARA LAW
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Regulation Number 868.1100

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Classification Product Code CBT
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Date Received 05/07/2007
Decision Date 08/01/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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