GETINGE 400HC/500HC SERIES STEAM STERILIZER


Device Classification Name

sterilizer, steam

510(k) Number K103504
Device Name GETINGE 400HC/500HC SERIES STEAM STERILIZER
Applicant
GETINGE SOURCING, LLC
1777 east henrietta road
rochester, 
NY 
14623

Applicant Contact barb smith
Correspondent
GETINGE SOURCING, LLC
1777 east henrietta road
rochester, 
NY 
14623

Correspodent Contact barb smith
Regulation Number 880.6880
Classification Product Code
FLE  
Date Received 11/26/2010
Decision Date 03/16/2011
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