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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 K991959
Device Name PSI TITANIUM ANEURYSM CLIP
Applicant
V. Mueller Neuro/Spine
360 Industrial Rd., Unit H
San Carlos,  CA  94070
Applicant Contact TERRY JOHNSTON
Correspondent
V. Mueller Neuro/Spine
360 Industrial Rd., Unit H
San Carlos,  CA  94070
Correspondent Contact TERRY JOHNSTON
Regulation Number882.5200
Classification Product Code
HCH  
Subsequent Product Code
HCI  
Date Received06/10/1999
Decision Date 01/06/2000
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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