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FDA 510(k) Application Details - K172800
Device Classification Name
Needle, Spinal, Short Term
More FDA Info for this Device
510(K) Number
K172800
Device Name
Needle, Spinal, Short Term
Applicant
Smiths Medical ASD, Inc.
6000 Nathan Lane North
Minneapolis, MN 55442 US
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Contact
Michael R. Johnson
Other 510(k) Applications for this Contact
Regulation Number
868.5150
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Classification Product Code
MIA
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More FDA Info for this Product Code
Date Received
09/18/2017
Decision Date
06/14/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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