Device Classification Name |
Sterilizer, Steam
|
510(k) Number |
K122625 |
Device Name |
GETINGE 800HC- 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
|
|
Correspondent Contact |
BARB SMITH |
Regulation Number | 880.6880
|
Classification Product Code |
|
Date Received | 08/28/2012 |
Decision Date | 05/22/2013 |
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
|
|
|