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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 K031468
Device Name TEMPORARY TITANIUM ANEURYSM CLIP
Applicant
Cardinalhealth
1500 Waukegan Rd., Bldg. Wm
Mcgaw Park,  IL 
Applicant Contact LANCE MACRCONI
Correspondent
Cardinalhealth
1500 Waukegan Rd., Bldg. Wm
Mcgaw Park,  IL 
Correspondent Contact LANCE MACRCONI
Regulation Number882.5200
Classification Product Code
HCH  
Subsequent Product Code
HCI  
Date Received05/09/2003
Decision Date 06/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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