The following data is part of a premarket notification filed by Wipak Oy with the FDA for Steriking Packaging For Medical Devices.
| Device ID | K221016 |
| 510k Number | K221016 |
| Device Name: | Steriking Packaging For Medical Devices |
| Classification | Wrap, Sterilization |
| Applicant | Wipak OY Wipaktie 2 Nastola, FI Fi-15560 |
| Contact | Hanna Marttila |
| Correspondent | Steven T Singleton Compliance Systems International LLC 7 Windham Hill Mendon, NY 14506 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-05 |
| Decision Date | 2022-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438263665560 | K221016 | 000 |
| 06438263665522 | K221016 | 000 |