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FDA 510(k) Application Details - K982128
Device Classification Name
Tube Tracheostomy And Tube Cuff
More FDA Info for this Device
510(K) Number
K982128
Device Name
Tube Tracheostomy And Tube Cuff
Applicant
PILLING WECK SURGICAL
420 DELAWARE DR.
FORT WASHINGTON, PA 19034 US
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Contact
ELIZABETH LAZARO
Other 510(k) Applications for this Contact
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
06/17/1998
Decision Date
10/23/1998
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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