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FDA 510(k) Application Details - K071269
Device Classification Name
Arterial Blood Sampling Kit
More FDA Info for this Device
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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More FDA Info for this Product Code
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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