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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 K902116
Device Name MODIFIED ENDOBRONCHIAL TUBE
Applicant
Concord/Portex
15 Kitt St.
Keene,  NH  03431
Applicant Contact EDWIN G GROVE
Correspondent
Concord/Portex
15 Kitt St.
Keene,  NH  03431
Correspondent Contact EDWIN G GROVE
Regulation Number868.5720
Classification Product Code
BTS  
Date Received05/10/1990
Decision Date 08/03/1990
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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