STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM


Device Classification Name

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

510(k) Number K112593
Device Name STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
Applicant
STRYKER CORPORATION
4100 e. milham ave
kalamazoo, 
MI 
49001

Applicant Contact michelle jump
Correspondent
STRYKER CORPORATION
4100 e. milham ave
kalamazoo, 
MI 
49001

Correspodent Contact michelle jump
Regulation Number 874.4250
Classification Product Code
ERL  
Date Received 09/07/2011
Decision Date 05/01/2012
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