|
Device |
sterilizer, steam |
Product Code | FLE |
Regulation Number |
880.6880
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ASTELL SCIENTIFIC LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BELIMED AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BELIMED SAUTER AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BELIMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CEFLA S.C. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONSOLIDATED MACHINE CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENBIO GROUP AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FORT DEFIANCE INDUSTRIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FORT DEFIANCE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GETINGE SOURCING LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GETINGE SOURCING, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAQUET GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MIDMARK CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIDMARK CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MILTON E PEDRAZZI D.D.S., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRIMUS STERILIZER COMPANY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PRIMUS STERILIZER COMPANY, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
REVOLUTIONARY SCIENCE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAKURA SEIKI CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SAUTER AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SCICAN LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SHINVA MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STEELCO S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERIS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERIS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
14
|
STURDY INDUSTRIAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TUTTNAUER CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TUTTNAUER LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TUTTNAUER U.S.A CO, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TUTTNAUER USA CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
W&H STERILIZATION S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
|
|
|
|