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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cuff, tracheal tube, inflatable
510(k) Number K902114
Device Name CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR
Original Applicant
DIEMOLDING CORP.
125 rasbach st.
canastota,  NY  13032
Original Contact jean wallace
Regulation Number868.5750
Classification Product Code
BSK  
Date Received05/11/1990
Decision Date 07/18/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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