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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 K925505
Device Name RUSCH SAFETY CLEAR PLUS CUFFED W/MURPHY EYE
Applicant
Rusch, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact RICHARD T LYKINS
Correspondent
Rusch, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact RICHARD T LYKINS
Regulation Number868.5730
Classification Product Code
BTR  
Date Received10/30/1992
Decision Date 09/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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