STRYKER ESSX WITH NAVIGATION MOUNT


Device Classification Name

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

510(k) Number K080052
Device Name STRYKER ESSX WITH NAVIGATION MOUNT
Applicant
STRYKER CORP.
4100 east milham ave.
kalamazoo, 
MI 
49001

Applicant Contact valerie franck
Correspondent
STRYKER CORP.
4100 east milham ave.
kalamazoo, 
MI 
49001

Correspodent Contact valerie franck
Regulation Number 874.4250
Classification Product Code
ERL  
Date Received 01/08/2008
Decision Date 10/02/2008
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