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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 K931166
Device Name RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY
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 Received03/08/1993
Decision Date 06/22/1993
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
Recalls CDRH Recalls
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