The following data is part of a premarket notification filed by Avalign Technologies, Inc. with the FDA for Steripack Cases And Tray Systems.
| Device ID | K193066 |
| 510k Number | K193066 |
| Device Name: | Steripack Cases And Tray Systems |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Avalign Technologies, Inc. 8727 Clinton Park Dive Fort Wayne, IN 46825 |
| Contact | Hiren Patel |
| Correspondent | Heidi Funston Avalign Technologies, Inc. 8727 Clinton Park Dive Fort Wayne, IN 46825 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-04 |
| Decision Date | 2020-08-06 |