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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Bronchial (W/Wo Connector)
510(k) Number K951091
Device Name RUSCH ENDOBRONCHIAL TUBE SETS
Applicant
Rusch Intl.
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact NEIL R ARMSTRONG
Correspondent
Rusch Intl.
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact NEIL R ARMSTRONG
Regulation Number868.5720
Classification Product Code
BTS  
Date Received03/09/1995
Decision Date 06/08/1995
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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