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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
JAFFREY,  NH  03452
Applicant Contact NEIL R ARMSTRONG
Correspondent
RUSCH INTL.
TALL PINES PARK
JAFFREY,  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
Recalls CDRH Recalls
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