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FDA 510(k) Application Details - K953559
Device Classification Name
Tube, Tracheostomy (W/Wo Connector)
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510(K) Number
K953559
Device Name
Tube, Tracheostomy (W/Wo Connector)
Applicant
SEIDEL MEDIZIN GMBH
16 STOCKDORFER WEG
BUCHENDORF D-82131 DE
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Contact
MARTHA STRASSER
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Regulation Number
868.5800
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Classification Product Code
BTO
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More FDA Info for this Product Code
Date Received
06/20/1995
Decision Date
05/16/1996
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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