The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Century Medium Sterilizer 26 X 26.
Device ID | K020747 |
510k Number | K020747 |
Device Name: | AMSCO CENTURY MEDIUM STERILIZER 26 X 26 |
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 | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-07 |
Decision Date | 2002-05-17 |
Summary: | summary |