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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tracheal, Preformed/Molded
510(k) Number K894380
Device Name DUMON TRACHEOBRONCHIAL STENT
Applicant
Bryan Corp.
Four Plympton St.
Woburn,  MA  01801
Applicant Contact FRANK M ABRANO
Correspondent
Bryan Corp.
Four Plympton St.
Woburn,  MA  01801
Correspondent Contact FRANK M ABRANO
Regulation Number878.3720
Classification Product Code
NWA  
Date Received07/17/1989
Decision Date 10/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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