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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 K951046
Device Name RUSCH ENDOTEST CUFF PRESSURE MONITOR
Applicant
RUSCH INTL.
TALL PINES PARK
JAFFREY,  NH  03452
Applicant Contact NEIL R ARMSTRONG
Correspondent
RUSCH INTL.
TALL PINES PARK
JAFFREY,  NH  03452
Correspondent Contact NEIL R ARMSTRONG
Regulation Number868.5750
Classification Product Code
BSK  
Date Received03/06/1995
Decision Date 04/06/1995
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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