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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 K161376
Device Name DragonFly Surgical Drill System
Applicant
Grace Medical, Inc.
8500 Wolf Lake Drive
Suite 110
Memphis,  TN  38133
Applicant Contact William Graham
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number874.4250
Classification Product Code
ERL  
Date Received05/18/2016
Decision Date 08/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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