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FDA 510(k) Application Details - K991259
Device Classification Name
Catheter, Conduction, Anesthetic
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510(K) Number
K991259
Device Name
Catheter, Conduction, Anesthetic
Applicant
TE ME NA S.A.R.L.
390 SCARLET BLVD.
OLDSMAR, FL 34677 US
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Contact
JOE HARMS
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Regulation Number
868.5120
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Classification Product Code
BSO
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More FDA Info for this Product Code
Date Received
04/13/1999
Decision Date
02/21/2001
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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