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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K021777
Device Name GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)
Applicant
Gyrus Ent LLC
2925 Appling Rd.
Bartlett,  TN  38133
Applicant Contact JEFFREY W COBB
Correspondent
Gyrus Ent LLC
2925 Appling Rd.
Bartlett,  TN  38133
Correspondent Contact JEFFREY W COBB
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/30/2002
Decision Date 08/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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