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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 K990221
Device Name INTRACOIL PERIPHERAL STENT
Applicant
INTRATHERAPEUTICS, INC.
6271 BURY DR.
EDEN PRAIRIE,  MN  55346
Applicant Contact AMY PETERSON
Correspondent
INTRATHERAPEUTICS, INC.
6271 BURY DR.
EDEN PRAIRIE,  MN  55346
Correspondent Contact AMY PETERSON
Regulation Number878.3720
Classification Product Code
JCT  
Date Received01/22/1999
Decision Date 06/02/1999
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
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