Device Classification Name |
Sterilizer, Steam
|
510(k) Number |
K980014 |
Device Name |
THE SYSTEM 2S STEAM STERILIZER |
Applicant |
STERIS Corporation |
2424 WEST 23RD ST. |
ERIE,
PA
16506
|
|
Applicant Contact |
RAYMOND URSICK |
Correspondent |
STERIS Corporation |
2424 WEST 23RD ST. |
ERIE,
PA
16506
|
|
Correspondent Contact |
RAYMOND URSICK |
Regulation Number | 880.6880
|
Classification Product Code |
|
Date Received | 01/02/1998 |
Decision Date | 05/15/1998 |
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
|
|
|