The following data is part of a premarket notification filed by Mast Biosurgery with the FDA for Ortho-wrap Bioresorbable Sheet.
| Device ID | K072190 |
| 510k Number | K072190 |
| Device Name: | ORTHO-WRAP BIORESORBABLE SHEET |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | MAST BIOSURGERY 6749 TOP GUN STREET, SUITE 108 San Diego, CA 92121 |
| Contact | Kenneth K Kleinhenz |
| Correspondent | Kenneth K Kleinhenz MAST BIOSURGERY 6749 TOP GUN STREET, SUITE 108 San Diego, CA 92121 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-06 |
| Decision Date | 2008-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18964050475012 | K072190 | 000 |
| 18964050472011 | K072190 | 000 |
| 00810057380334 | K072190 | 000 |
| 00810057380389 | K072190 | 000 |