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FDA 510(k) Application Details - K970997
Device Classification Name
Needle, Spinal, Short Term
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510(K) Number
K970997
Device Name
Needle, Spinal, Short Term
Applicant
KLEIN-BAKER MEDICAL, INC.
12001 NETWORK, SUITE 110
SAN ANTONIO, TX 78249 US
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Contact
CLYDE N BAKER
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
03/19/1997
Decision Date
05/22/1997
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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