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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, Expandable, Polymeric
510(k) Number K953593
Device Name RUSCH TRACHEAL BRONCHIAL Y STENT
Applicant
Rusch, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Applicant Contact KARENANN J BROZOWSKI
Correspondent
Rusch, Inc.
Tall Pines Park
Jeffrey,  NH  03452
Correspondent Contact KARENANN J BROZOWSKI
Regulation Number878.3720
Classification Product Code
NYT  
Date Received07/31/1995
Decision Date 10/13/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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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