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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K945586
Device Name FLEXIBLE DILATING SHEATH
Applicant
Med Institute, Inc.
P.O.Box 2402
West Lafayette,  IN  47906
Applicant Contact NEAL E FEARNOT
Correspondent
Med Institute, Inc.
P.O.Box 2402
West Lafayette,  IN  47906
Correspondent Contact NEAL E FEARNOT
Regulation Number870.1310
Classification Product Code
DRE  
Date Received11/14/1994
Decision Date 04/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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