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FDA 510(k) Application Details - K041044
Device Classification Name
Tube Tracheostomy And Tube Cuff
More FDA Info for this Device
510(K) Number
K041044
Device Name
Tube Tracheostomy And Tube Cuff
Applicant
COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON, IN 47402-0489 US
Other 510(k) Applications for this Company
Contact
JENNIFER BOSLEY
Other 510(k) Applications for this Contact
Regulation Number
868.5800
More FDA Info for this Regulation Number
Classification Product Code
JOH
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More FDA Info for this Product Code
Date Received
04/22/2004
Decision Date
07/29/2004
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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