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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K954713
Device Name DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
Applicant
IDEAS FOR MEDICINE, INC.
12167 49TH ST. NORTH
P.O. BOX 17327
CLEARWATER,  FL  34622
Applicant Contact ELIZABETH M PAUL
Correspondent
IDEAS FOR MEDICINE, INC.
12167 49TH ST. NORTH
P.O. BOX 17327
CLEARWATER,  FL  34622
Correspondent Contact ELIZABETH M PAUL
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/10/1995
Decision Date 07/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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