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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 K013266
Device Name RUSCH POLYFLEX STENT KIT
Applicant
Rusch Intl.
50 Plantation Dr.
Jaffrey,  NH  03452
Applicant Contact KARENANN J BROZOWSKI
Correspondent
Rusch Intl.
50 Plantation Dr.
Jaffrey,  NH  03452
Correspondent Contact KARENANN J BROZOWSKI
Regulation Number878.3720
Classification Product Code
NYT  
Date Received10/01/2001
Decision Date 11/27/2001
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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