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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Methyl Methacrylate For Cranioplasty
510(k) Number K162864
Device Name OsteoVation Impact
Applicant
Skeletal Kinetics, LLC
10201 Bubb Rd.
Cupertino,  CA  95014
Applicant Contact Alicia Hemphill
Correspondent
Skeletal Kinetics, LLC
10201 Bubb Rd.
Cupertino,  CA  95014
Correspondent Contact Alicia Hemphill
Regulation Number882.5300
Classification Product Code
GXP  
Date Received10/13/2016
Decision Date 01/13/2017
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
Recalls CDRH Recalls
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