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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 K041269
Device Name ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
Applicant
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON,  NH  03051
Applicant Contact JOSEPH P DE PAOLO
Correspondent
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON,  NH  03051
Correspondent Contact JOSEPH P DE PAOLO
Regulation Number878.3720
Classification Product Code
JCT  
Date Received05/12/2004
Decision Date 09/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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