DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE

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 L.L.C.
2925 appling rd.
bartlett, 
TN 
38133

Applicant Contact alicia farage
Correspondent
GYRUS ENT L.L.C.
2925 appling rd.
bartlett, 
TN 
38133

Correspodent Contact alicia farage
Regulation Number 874.4250
Classification Product Code
ERL  
Date Received 12/24/2003
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