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FDA 510(k) Application Details - K973829
Device Classification Name
Tube Tracheostomy And Tube Cuff
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510(K) Number
K973829
Device Name
Tube Tracheostomy And Tube Cuff
Applicant
AUTOMATIC LIQUID PACKAGING, INC.
2200 W. LAKE SHORE DR.
WOODSTOCK, IL 60098 US
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Contact
JOHN BRDA
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Regulation Number
868.5800
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Classification Product Code
JOH
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More FDA Info for this Product Code
Date Received
10/07/1997
Decision Date
02/23/1998
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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