The following data is part of a premarket notification filed by Steris Corporation with the FDA for Sterilization Mats.
Device ID | K103226 |
510k Number | K103226 |
Device Name: | STERILIZATION MATS |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | Robert F Sullivan |
Correspondent | Robert F Sullivan STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-01 |
Decision Date | 2011-02-18 |
Summary: | summary |