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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
Model 70138400
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 (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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