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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name drill, surgical, ent (electric or pneumatic) including handpiece
510(k) Number K121678
Device Name DTAD
Original Applicant
GYRUS ACMI, INC.
136 turnpike rd.
southborough,  MA  01772
Original Contact dolan mills
Regulation Number874.4250
Classification Product Code
ERL  
Date Received06/07/2012
Decision Date 08/30/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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