The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify Challenge Packs, Models 270f 4 Challenge Pack; 275f 3 Challenge Pack; 275f 10 Challenge Pack.
| Device ID | K070895 |
| 510k Number | K070895 |
| Device Name: | VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK |
| 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 | 2007-03-30 |
| Decision Date | 2007-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995088979 | K070895 | 000 |
| 10724995088955 | K070895 | 000 |
| 10724995218574 | K070895 | 000 |
| 10724995218550 | K070895 | 000 |