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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Scalp
510(k) Number K050044
Device Name MEDTRONIC CLIP GUN KIT
Applicant
Medtronic Neurosurgery
125 Cremona Dr.
Goleta,  CA  93117
Applicant Contact JEFFREY HENDERSON
Correspondent
Medtronic Neurosurgery
125 Cremona Dr.
Goleta,  CA  93117
Correspondent Contact JEFFREY HENDERSON
Regulation Number882.4150
Classification Product Code
HBO  
Date Received01/10/2005
Decision Date 02/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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