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FDA 510(k) Application Details - K954771
Device Classification Name
Stylet, Tracheal Tube
More FDA Info for this Device
510(K) Number
K954771
Device Name
Stylet, Tracheal Tube
Applicant
LAERDAL MEDICAL CORP.
167 MYERS CORNERS RD.
P.O. BOX 1840
WAPPINGERS FALLS, NY 12590-8840 US
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Contact
KEN HERLAND
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Regulation Number
868.5790
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Classification Product Code
BSR
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More FDA Info for this Product Code
Date Received
10/17/1995
Decision Date
05/09/1996
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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