STRYKER ESSX MICRODEBRIDER SYSTEM


Device Classification Name

drill, surgical, ent (electric or pneumatic) including handpiece

510(k) Number K073633
Device Name STRYKER ESSX MICRODEBRIDER SYSTEM
Applicant
STRYKER IRELAND LTD., INSTRUMENTS DIVISION
carrigtwohill business &
technology park
carrigtwohill, co.cork, 

IE

Applicant Contact colette o’connor
Correspondent
STRYKER IRELAND LTD., INSTRUMENTS DIVISION
carrigtwohill business &
technology park
carrigtwohill, co.cork, 

IE

Correspodent Contact colette o’connor
Regulation Number 874.4250
Classification Product Code
ERL  
Date Received 12/26/2007
Decision Date 08/26/2008
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