The following data is part of a premarket notification filed by Mast Biosurgery Usa Inc. with the FDA for Surgi-wrap Mast Bioresorbable Sheet.
| Device ID | K050332 |
| 510k Number | K050332 |
| Device Name: | SURGI-WRAP MAST BIORESORBABLE 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 | 2005-02-10 |
| Decision Date | 2005-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18964050275063 | K050332 | 000 |
| 00810057380167 | K050332 | 000 |
| 00810057380181 | K050332 | 000 |
| 00810057380198 | K050332 | 000 |
| 08964050272010 | K050332 | 000 |
| 08964050272027 | K050332 | 000 |
| 18964050272048 | K050332 | 000 |
| 18964050272062 | K050332 | 000 |
| 08964050275011 | K050332 | 000 |
| 08964050275028 | K050332 | 000 |
| 08964050275042 | K050332 | 000 |
| 00810057380136 | K050332 | 000 |