The following data is part of a premarket notification filed by Steris Corporation with the FDA for Verify 275f Gravity Indicators.
| Device ID | K083643 |
| 510k Number | K083643 |
| Device Name: | VERIFY 275F GRAVITY INDICATORS |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | John Robert Scoville, Jr. |
| Correspondent | John Robert Scoville, Jr. 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 | 2008-12-09 |
| Decision Date | 2009-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995088054 | K083643 | 000 |
| 10724995088047 | K083643 | 000 |