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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, ureteral, gastro-urology
510(k) Number K033368
Device Name FOSSA URETERAL OPEN LUMEN STENT
Applicant
FOSSA MEDICAL, INC.
580 HARRISON AVE., 4TH FL.
BOSTON,  MA  02118
Applicant Contact GLORIA KOLB
Correspondent
FOSSA MEDICAL, INC.
580 HARRISON AVE., 4TH FL.
BOSTON,  MA  02118
Correspondent Contact GLORIA KOLB
Regulation Number876.5130
Classification Product Code
EYB  
Date Received10/21/2003
Decision Date 11/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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