The following data is part of a premarket notification filed by Steris Corporation with the FDA for System 1e Chemical Indicator.
| Device ID | K102217 |
| 510k Number | K102217 |
| Device Name: | SYSTEM 1E CHEMICAL INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| 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 | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-06 |
| Decision Date | 2010-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50724995092943 | K102217 | 000 |
| 10724995092945 | K102217 | 000 |
| 50724995229493 | K102217 | 000 |