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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drills, Burrs, Trephines & Accessories (Compound, Powered)
510(k) Number K141455
Device Name EASYDRILL AUTOSTOP CRANIAL PERFORATOR
Applicant
MICROMAR IND. COM. LTD.
4620 NORTH BEACH STREET
FORT WORTH,  TX  76137
Applicant Contact DEEP PAL
Correspondent
MICROMAR IND. COM. LTD.
4620 NORTH BEACH STREET
FORT WORTH,  TX  76137
Correspondent Contact DEEP PAL
Regulation Number882.4305
Classification Product Code
HBF  
Date Received06/02/2014
Decision Date 03/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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