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FDA 510(k) Application Details - K964056
Device Classification Name
Tube Tracheostomy And Tube Cuff
More FDA Info for this Device
510(K) Number
K964056
Device Name
Tube Tracheostomy And Tube Cuff
Applicant
RUSCH INTL.
TALL PINES PARK
JAFFREY, NH 03452 US
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Contact
NEIL R ARMSTRONG
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
10/09/1996
Decision Date
10/10/1997
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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