The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator.
Device ID | K071895 |
510k Number | K071895 |
Device Name: | VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | John Scoville |
Correspondent | John Scoville STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-09 |
Decision Date | 2007-11-14 |
Summary: | summary |