The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Century Steam Sterilizer.
Device ID | K030789 |
510k Number | K030789 |
Device Name: | AMSCO CENTURY STEAM STERILIZER |
Classification | Sterilizer, Steam |
Applicant | STERIS Corporation 2424 WEST 23RD ST. Erie, PA 16506 |
Contact | Lori Haller |
Correspondent | Lori Haller STERIS Corporation 2424 WEST 23RD ST. Erie, PA 16506 |
Product Code | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-12 |
Decision Date | 2003-03-26 |
Summary: | summary |