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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name clip, aneurysm
510(k) Number K960372
Device Name SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM
Applicant
SCANLAN INTL., INC.
ONE SCANLAN PLAZA
ST PAUL,  MN  55107
Applicant Contact KEN BLAKE
Correspondent
SCANLAN INTL., INC.
ONE SCANLAN PLAZA
ST PAUL,  MN  55107
Correspondent Contact KEN BLAKE
Regulation Number882.5200
Classification Product Code
HCH  
Date Received01/26/1996
Decision Date 04/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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