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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K961840
Device Name RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY
Applicant
RUSCH INTL.
TALL PINES PARK
JAFFREY,  NH  03452
Applicant Contact KARENANN J BROZOWSKI
Correspondent
RUSCH INTL.
TALL PINES PARK
JAFFREY,  NH  03452
Correspondent Contact KARENANN J BROZOWSKI
Regulation Number868.5730
Classification Product Code
BTR  
Date Received05/13/1996
Decision Date 06/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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