GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)


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)
Original Applicant
GYRUS ENT L.L.C.
2925 appling rd.
bartlett, 
TN 
38133

Original Contact jeffrey w cobb
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 05/30/2002
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