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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Driver, Wire, And Bone Drill, Manual
510(k) Number K220648
Device Name OMF ASP System
Applicant
Vha Dean
810 Vermont Ave., NW
Washington,  DC  20420
Applicant Contact Beth Ripley
Correspondent
Lg Strategies, LLC
2001 Parker Lane #122
Austin,  TX  78741
Correspondent Contact Laura Gilmour
Regulation Number872.4120
Classification Product Code
DZJ  
Subsequent Product Code
LLZ  
Date Received03/07/2022
Decision Date 08/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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