GETINGE 400HC-E / SERIES STEAM STERILIZER


Device Classification Name

sterilizer, steam

510(k) Number K122071
Device Name GETINGE 400HC-E / SERIES STEAM STERILIZER
Applicant
GETINGE SOURCING LLC
1777 east henrietta rd.
rochester, 
NY 
14623 -3133

Applicant Contact barb smith
Correspondent
GETINGE SOURCING LLC
1777 east henrietta rd.
rochester, 
NY 
14623 -3133

Correspodent Contact barb smith
Regulation Number 880.6880
Classification Product Code
FLE  
Date Received 07/16/2012
Decision Date 03/12/2013
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