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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 K034004
Device Name DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
Applicant
Gyrus Ent LLC
2925 Appling Rd.
Bartlett,  TN  38133
Applicant Contact ALICIA FARAGE
Correspondent
Gyrus Ent LLC
2925 Appling Rd.
Bartlett,  TN  38133
Correspondent Contact ALICIA FARAGE
Regulation Number874.4250
Classification Product Code
ERL  
Date Received12/24/2003
Decision Date 03/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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