The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Process Indicator For Reliance Eps.
Device ID | K130160 |
510k Number | K130160 |
Device Name: | VERIFY PROCESS INDICATOR FOR RELIANCE EPS |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | Marcia L Benedict |
Correspondent | Marcia L Benedict STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-23 |
Decision Date | 2013-08-16 |
Summary: | summary |