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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K143191
FOIA Releasable 510(k) K143191
Device Name IntelliSense Drill
Applicant
Mcginley Innovations
2435 King Blvd., Suite 230
Casper,  WY  82604
Applicant Contact Joseph McGinley
Correspondent
MCRA, LLC
1331 H St. NW
12th Floor
Washington,  DC  20005
Correspondent Contact Justin Eggleton
Regulation Number878.4820
Classification Product Code
HWE  
Subsequent Product Codes
GEY   GFG   HTW  
Date Received11/06/2014
Decision Date 02/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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