OLYMPUS INSTRUMENT TRAY


Device Classification Name

sterilization wrap containers, trays, cassettes & other accessories

510(k) Number K110748
Device Name OLYMPUS INSTRUMENT TRAY
Applicant
OLYMPUS WINTER & IBE GMBH
3500 corporate pkway
center valley, 
PA 
18034 -0610

Applicant Contact stacy kluesner
Correspondent
OLYMPUS WINTER & IBE GMBH
3500 corporate pkway
center valley, 
PA 
18034 -0610

Correspodent Contact stacy kluesner
Regulation Number 880.6850
Classification Product Code
KCT  
Date Received 03/17/2011
Decision Date 02/15/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No