K210810 is an FDA 510(k) clearance for the Steiking Packaging for Medical Devices. This device is classified as a Wrap, Sterilization (Class II - Special Controls, product code FRG).
Submitted by Wipak OY (Nastola, FI). The FDA issued a Cleared decision on January 23, 2022, 312 days after receiving the submission on March 17, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K210810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2021 |
| Decision Date | January 23, 2022 |
| Days to Decision | 312 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRG - Wrap, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |