The following data is part of a premarket notification filed by Tissue Regenix Group Plc with the FDA for Surgipure Xd Reconstructive Tissue Matrix.
| Device ID | K152206 |
| 510k Number | K152206 |
| Device Name: | SurgiPure XD Reconstructive Tissue Matrix |
| Classification | Mesh, Surgical |
| Applicant | TISSUE REGENIX GROUP PLC THE BIOCENTRE, INNOVATION WAY, HESLINGTON York, GB Yo20 5ny |
| Contact | Mike Izon |
| Correspondent | Mike Izon TISSUE REGENIX GROUP PLC THE BIOCENTRE, INNOVATION WAY, HESLINGTON York, GB Yo20 5ny |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-06 |
| Decision Date | 2016-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060260020120 | K152206 | 000 |
| 05060260020021 | K152206 | 000 |
| 05060260020038 | K152206 | 000 |
| 05060260020045 | K152206 | 000 |
| 05060260020052 | K152206 | 000 |
| 05060260020069 | K152206 | 000 |
| 05060260020076 | K152206 | 000 |
| 05060260020083 | K152206 | 000 |
| 05060260020090 | K152206 | 000 |
| 05060260020106 | K152206 | 000 |
| 05060260020113 | K152206 | 000 |
| 05060260020014 | K152206 | 000 |