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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stripper, Artery, Intraluminal
510(k) Number K913803
Device Name INTRALUMINAL ARTERY STRIPPER
Applicant
Omni-Tract Surgical, Div. Minn. Scientific, Inc.
403 County Rd., E2 W.
St. Paul,  MN  55112
Applicant Contact DALE STULL
Correspondent
Omni-Tract Surgical, Div. Minn. Scientific, Inc.
403 County Rd., E2 W.
St. Paul,  MN  55112
Correspondent Contact DALE STULL
Regulation Number870.4875
Classification Product Code
DWX  
Date Received08/26/1991
Decision Date 04/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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