The following data is part of a premarket notification filed by Mast Biosurgery with the FDA for Surgiwrap Frost.
| Device ID | K200918 |
| 510k Number | K200918 |
| Device Name: | SurgiWrap FROST |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | MAST Biosurgery 6749 Top Gun St. Suite 108 San Diego, CA 92121 |
| Contact | Roel Trip |
| Correspondent | Kenneth K. Kleinhenz QSR Consulting 10807 Dakota Ranch Rd. Santee, CA 92071 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-06 |
| Decision Date | 2021-01-07 |