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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 K081640
Device Name GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
Applicant
GIMMI GMBH
ONE SCANLAN PLAZA
SAINT PAUL,  MN  55107
Applicant Contact KEN BLAKE
Correspondent
GIMMI GMBH
ONE SCANLAN PLAZA
SAINT PAUL,  MN  55107
Correspondent Contact KEN BLAKE
Regulation Number882.5200
Classification Product Code
HCH  
Subsequent Product Code
HCI  
Date Received06/11/2008
Decision Date 05/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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