The following data is part of a premarket notification filed by Mast Biosurgery Usa Inc. with the FDA for Surgi-wrap Mast Tendon Sheet.
| Device ID | K063648 |
| 510k Number | K063648 |
| Device Name: | SURGI-WRAP MAST TENDON SHEET |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | MAST BIOSURGERY USA INC. 6749 TOP GUN ST., SUITE C San Diego, CA 92121 |
| Contact | Kenneth K Kleinhenz |
| Correspondent | Kenneth K Kleinhenz MAST BIOSURGERY USA INC. 6749 TOP GUN ST., SUITE C 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 | 2006-12-07 |
| Decision Date | 2007-03-07 |
| Summary: | summary |