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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
510(k) Number K001257
Device Name INTRACOIL STENT
Applicant
Intratherapeutics, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Applicant Contact MARIA E BRITTLE
Correspondent
Intratherapeutics, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Correspondent Contact MARIA E BRITTLE
Regulation Number878.3720
Classification Product Code
JCT  
Date Received04/19/2000
Decision Date 05/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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